Staphylococcal InfectionPhase 2/3NCT00729937

Strategies Using Off-Patent Antibiotics for Methicillin Resistant S. Aureus "STOP MRSA"

A Phase 2/3 study testing Cephalexin, Clindamycin and Trimethoprim-sulfamethoxazole in people with Staphylococcal Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 13 years and older
Conditions the study is for: Staphylococcal Infection
What is being tested?: Cephalexin, Clindamycin and Trimethoprim-sulfamethoxazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,265 participants
Where: 5 sitesUnited States
Study dates: Apr 2009to Jun 2013
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Adult or child 13 years of age and older (who weighs greater than or equal to 40 kg);
Have a skin and soft tissue infection (SSTI) with all three local findings of erythema (> 2 cm across the lesion or from a discrete wound edge), tenderness, and swelling/induration. Fever, leukocytosis, and lymphangitis will be noted, but are not enrollment criteria. SSTI with these local findings will be further categorized and defined as one of:
Abscess - a fluctuant and/or indurated lesion, or findings of a fluid-filled cavity on soft tissue ultrasound evaluation that, when opened reveals purulent material, receiving incision and drainage (I\&D) (considered standard care for abscess) and having a minimum diameter (along any axis) of at least 2 cm (measured from the borders of induration, if a fluctuant lesion, or borders of the abscess cavity on ultrasound, if not fluctuant).
Note: Although I\&D of an abscess is considered standard care (i.e., patients will receive I\&D whether or not they are enrolled in the study), the procedure may be performed after enrollment into the study so that prior measurements of the area of erythema and swelling/induration can be obtained unless it is an occult abscess in which the I\&D will be performed prior to enrollment to verify infection type and ensure correct classification of the subject.
Infected Wound - a wound (defined as any apparent break in the skin) with any apparent drainage limited in depth to only involving skin and subcutaneous tissue, including sutured cutaneous wounds not involving intra-abdominal surgeries contaminated with bacterial or bowel contents (e.g., colon surgery and empyema drainage), and
Cellulitis - an area of erythema without the presence of a wound with drainage or abscess; Cellulitis associated with an abscess will be categorized as an abscess. Cellulitis associated with an infected wound will be classified as an infected wound. Patients with cellulitis and an abscess less than 2 cm will be excluded. Infected wound associated with an abscess that may require I\&D, will be classified as an infected wound.

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Have the infected lesion for 7 days or less duration;
Are to receive outpatient treatment at enrollment/baseline;
Express willingness and ability to be contacted and return for re-evaluation according to the study protocol;
Provide written informed consent (and for subjects ages 13-17, consent from their guardian and assent);
Negative pregnancy test for subjects who are women of childbearing potential.

Who cannot join

Severe allergy or reaction to study drug or drugs similar to the study drug relevant to whichever study sub-trial the subject would be assigned to (e.g., patients with severe or life-threatening penicillin allergies, allergy to any cephalosporin, clindamycin, or sulfonamides, or any other drug containing sulfur such as thiazides, furosemide, and oral sulfonylureas);
Concomitant treatment (i.e., while on study drug therapy) with coumadin, phenytoin, or methotrexate, or suspected G-6-PD or folic acid deficiency;
Expected inability to swallow or absorb the study drug (assessed by patient history);
Pregnancy, nursing, or expectation of becoming pregnant while on study drug;
Perirectal (within 5 cm of anus), perineal non-skin lesions (i.e., mucosal), or paronychial location of infection. Scrotal and labial abscesses will not be excluded.
An infection due to a mammalian bite;

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Treatment with a study drug relevant to their infection type, or another systemic antibiotic in the previous 48 hours (i.e., before screening/baseline) unless associated with treatment failure which is defined as a patient who has been on prior (non study drug) antibiotics for at least 72 hours and failed.
Expected concurrent treatment with a topical antibiotic or another systemic antibiotic up to Test-of-Cure Visit (TOC) (note: if patient was using a topical antibiotic previously, they can still be enrolled if they agree to stop using it);
Immunodeficiency [e.g., absolute neutrophil count <500/mm^3, chronic immunosuppressive drugs, active chemotherapy, or known acquired immunodeficiency syndrome (AIDS) (CD4 count <200 or AIDS-defining illness within the last year) assessed by patient history]. Note: patients who had prior AIDS-defining illness or CD4 count <200 in the past may be enrolled if most recent CD4 count >200;
Burn or active chronic skin condition (e.g., including rash or eczema) related to the skin and soft-tissue infection (SSTI) at screening/baseline;
Infection related to currently indwelling device (e.g., intravenous line), excepting sutures associated with qualifying infected wounds which will be removed upon enrollment;
Infection for which prior cultures reveal in vitro resistance of a pathogen to a study drug in the previous month prior to screening/baseline;
Known or suspected osteomyelitis or septic arthritis;
Infection related to diabetic foot, decubitus, or ischemic ulcer;
Known severe renal insufficiency (creatinine clearance < 50 mL/min) calculated by measurement of serum creatinine if patient provides this history or based on past studies at baseline/enrollment;
Prior enrollment in this study within 12 weeks;
Another active infection of another organ system (e.g., pneumonia) or more than one active (i.e., currently on antibiotic treatment and/or requiring I\&D) SSTI site (e.g., a site noncontiguous with the infection under study). Note: Minor folliculitis at secondary site is not an exclusion;
Presence of an abscess that has completely drained, either spontaneously or by a healthcare provider prior to enrollment;
An infected wound or cellulitis that has been surgically explored (>1 cm incision) and does not reveal an abscess. Cellulitis that has been needled, minimally incised (less than or equal to 1 cm) or punch biopsied and no purulent drainage found can still be enrolled;
Currently incarcerated in a detention facility or in police custody (note: patients wearing a monitoring device can be enrolled) at baseline/screening;
For patients with an infected wound, history of C. difficile infection, pseudomembranous colitis, or active diarrhea at baseline/screening;
For patients with an infected wound, severe liver disease based on patient history;
An intravenous (IV) drug user in the last month with current presence of fever;
Current residence in a nursing home or other long term care facility at baseline/screening;
Expected use of other investigational drug or vaccine while on study drug;
For patients with an abscess, cardiac conditions associated with the highest risk of adverse outcome from endocarditis for which prophylaxis is reasonable, including patients with prosthetic cardiac valve or prosthetic material used for cardiac valve repair, history of previous infective endocarditis, congenital heart disease (excluding mitral valve prolapse), and history of cardiac transplantation recipients who develop cardiac valvulopathy;
Presence of an organic foreign body, e.g., wood (note: subjects with embedded non-organic materials, e.g., metal or glass, that can be completely removed can still be enrolled if physician is certain there is no foreign body left).

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Johns Hopkins University at Mount Washington - Emergency Medicine
Baltimore, Maryland, 21209-3652
Truman Medical Center - Hospital Hill
Kansas City, Missouri, 64108-2640
Temple University Hospital
Philadelphia, Pennsylvania, 19140-5103
Maricopa Medical Center - Emergency Medicine
Phoenix, Arizona, 85008-4973
University of California Los Angeles - Olive View Medical Center
Sylmar, California, 91342-1437

Other trials in United States

About this study

Official title: Strategies Using Off-Patent Antibiotics for Methicillin-Resistant Staphylococcus Aureus ("STOP MRSA") - A Phase IIB, Multi-Center, Randomized, Double-Blind Clinical Trial

The purpose of this study is to determine the optimal outpatient treatment strategy of uncomplicated skin and soft tissue infection (SSTI) in areas of the United States where the prevalence of Community-Acquired Methicillin-Resistant Staphylococcus (S.) aureus (CA-MRSA) is high. Infection with the S. aureus bacteria that is resistant to antibiotics is a cause of SSTIs. Three oral antibiotics will be tested for off patent treatment. Patients will receive Trimethoprim/Sulfamethoxazole (TMP/SMX), placebo (substance containing no medication), clindamycin, or cephalexin or some combination of these. The study population will include 2,235 volunteers, children 13 years of age and over and adults presenting to 5 large urban Emergency Departments. Therapy for acute uncomplicated SSTIs, including abscess, infected wound, and cellulitis will start on the day of enrollment. Participants may be involved in study related procedures for about 9 weeks.

Read the detailed description

Community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) has recently emerged as a cause of skin and soft-tissue infection (SSTI). In the current era of increasing CA-MRSA infections, the outpatient management of SSTIs has not been well studied. This will be a clinical trial to evaluate oral off-patent antibiotics for outpatient treatment of patients with any of the 3 main types of acute uncomplicated SSTI, i.e., abscesses, infected wounds, and cellulitis. Upon enrollment, subjects will be stratified by type of infection, and then randomized to various treatments. Subjects with an acute uncomplicated cutaneous abscess receiving incision and drainage (I\&D) will be treated with Trimethoprim/Sulfamethoxazole (TMP/SMX) or placebo to determine whether the addition of an antibiotic with activity against CA-MRSA is more clinically efficacious than I\&D alone. Subjects with an acute wound infection will be treated with TMP/SMX or clindamycin to determine if clindamycin, an antibiotic with activity against CA-MRSA, methicillin-susceptible Staphylococcus aureus (MSSA), and streptococci is more clinically efficacious than TMP/SMX, an antibiotic with activity against CA-MRSA and MSSA. Subjects with acute cellulitis will be treated with cephalexin/TMP/SMX or cephalexin/placebo to determine if cephalexin/TMP/SMX is more clinically efficacious than cephalexin alone. The primary objectives for each type of SSTI studied are to compare the cure rates in the per protocol (PP) population. Secondary objectives provide additional means of assessment for the clinical efficacy of the employed interventions and resolution of the infection and include describing microbiological cure, change in the dimension of erythema, composite cure, surgical procedures, invasive and recurrent infections, infections in household contacts, and time to normal activity and until analgesics are no longer used at various times in the PP/ modified intent-to-treat (mITT) populations. This is a multi-center, randomized, double-blind clinical trial in which subjects will be stratified by the type of infection and then randomized to various 7-day oral antibiotic treatments, including placebo-controlled and comparative designs. The study population will include children 13 years of age and over and adults, who weigh greater than or equal to 40 kg presenting to 5 large urban emergency departments. Therapy will start on the day of enrollment. Subjects will be evaluated upon enrollment, at 2-3 days after enrollment (OTV), at 1-3 days after the end-of-therapy (EOT), at 7-14 days after the end-of-therapy (TOC), and at 6-8 weeks after the end-of-therapy (EFV).

Conditions: Staphylococcal Infection
Being tested: Cephalexin, Clindamycin, Placebo, Trimethoprim-sulfamethoxazole
Keywords: Methicillin, Staphylococcus aureus, MRSA
Medical subject headings: Staphylococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CephalexinDrug
500 mg, four times per day.
ClindamycinDrug
300 mg, four times per day.
PlaceboOther
Placebo tablet administered orally.
Trimethoprim-sulfamethoxazoleDrug
4 single strength Trimethoprim/Sulfamethoxazole (TMP/SMX), 80 mg/400 mg each, twice per day.

Study groups in NCT00729937
Study group	Role	What they receive
TMP/SMX vs. Placebo	Experimental	Subjects with an acute uncomplicated cutaneous abscess will be randomized to receive either Trimethoprim/Sulfamethoxazole (TMP/SMX) (4 single strength pills, 80 mg/400 mg each, twice per day) or 4 placebo pills (twice per day). Receives: Other: Placebo; Drug: Trimethoprim-sulfamethoxazole
TMP/SMX vs. Clindamycin	Experimental	Subjects with an acute uncomplicated wound infection will be randomized to receive Trimethoprim/Sulfamethoxazole (TMP/SMX) (4 single strength pills, 80 mg/400 mg each, twice per day, with alternating 1 identical placebo pill, twice per day) or clindamycin (300 mg, four times per day, with 3 placebo pills on alternating doses). Receives: Drug: Clindamycin; Other: Placebo; Drug: Trimethoprim-sulfamethoxazole
Cephalexin and TMP/SMX vs. Cephalexin	Experimental	Subjects with acute uncomplicated cellulitis will be randomized to receive cephalexin (500 mg, four times per day) and Trimethoprim/Sulfamethoxazole (TMP/SMX) (4 single strength pills, 80 mg/400 mg each, twice per day) or cephalexin (500 mg, four times per day) and placebo (4 pills, twice per day). Receives: Drug: Cephalexin; Other: Placebo; Drug: Trimethoprim-sulfamethoxazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population
Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.
Measured: Days 14-21

Secondary outcomes (30)

Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population
Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.
Measured: Days 14-21
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Measured: Day 1 to Day 3-4
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Measured: Day 1 to Day 3-4
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Measured: Day 1 to Day 8-10
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Measured: Day 1 to Day 8-10
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Measured: Day 1 to Day 14-21
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
Measured: Day 1 to Day 14-21
Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population
Participants were categorized as composite clinical cure if they had resolution of all symptoms/signs of infection, or improvement to such an extent that no additional antibiotic therapy and/or surgical procedures were necessary. Participants were categorized as composite clinical failure if they had lack of resolution of all signs and symptoms of infection to such an extent that further antibiotic therapy and/or surgical procedures were necessary.
Measured: Day 14-21
Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population
Participants were categorized for the microbiological outcome with Presumed eradication if they were not deemed a clinical failure through TOC. Those who were deemed a clinical failure through the TOC were classified as one of the following: Persistence=persistent growth of a pre-therapy pathogen; New infection=growth of a new pathogen and eradication of initial pathogen; Super-infection=growth of a new pathogen in addition to persistent growth of pre-therapy pathogen; Unclassified=no specimen for culture or growth of a pathogen in subsequent culture specimen of cellulitis participants, or for whom initial culture specimens were negative or were not obtained for infected wound and abscess participants; or Indeterminate=not meeting any one of the above microbiologic outcome criteria.
Measured: Day 14-21
Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population
All surgical procedures such as incision and drainage (I\&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I\&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I\&D as applicable) and the test-of-cure visit are summarized.
Measured: Day 1 through Day 14-21
Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population
All surgical procedures such as incision and drainage (I\&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I\&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I\&D as applicable) and the test-of-cure visit are summarized.
Measured: Day 1 through Day 14-21
Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population
All surgical procedures such as incision and drainage (I\&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I\&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I\&D as applicable) and the extended follow-up visit are summarized.
Measured: Day 1 through Day 49-63
Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population
All surgical procedures such as incision and drainage (I\&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I\&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I\&D as applicable) and the extended follow-up visit are summarized.
Measured: Day 1 through Day 49-63
Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.
Measured: Day 1 through Day 14-21
Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.
Measured: Day 1 through Day 14-21
Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.
Measured: Day 1 through Day 49-63
Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.
Measured: Day 1 through Day 49-63
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population
Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.
Measured: Day 1 through Day 14-21
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population
Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.
Measured: Day 1 through Day 14-21
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population
Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.
Measured: Day 1 through Day 49-63
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population
Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.
Measured: Day 1 through Day 49-63
Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population
At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.
Measured: Day 1 through Day 14-21
Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population
At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.
Measured: Day 1 through Day 14-21
Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population
At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.
Measured: Day 1 through Day 49-63
Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population
At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.
Measured: Day 1 through Day 49-63
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
All adverse events were recorded through the test of cure visit; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit. All AEs were assessed for association with the study product by a clinician and were considered associated with study product if the event was temporally related to the administration of the study product and no other etiology more likely explains the event. Associated adverse events are summarized by MedDRA System Organ Class.
Measured: Day 1 through Day 49-63
Mean Days Missed From Normal Activities in the Per Protocol Population
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.
Measured: Day 1 through 14
Mean Days Missed From Normal Activities in the Intent to Treat Population
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.
Measured: Day 1 through 14
Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.
Measured: Day 1 through 14
Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.
Measured: Day 1 through 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Jun 2013

First posted8 Aug 2008 (estimated)
Study startApr 2009
Primary completionMay 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Staphylococcal InfectionStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 2,265 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00729937
Sponsor's protocol ID: 07-0040
Status last verified: Sep 2013
First submitted: 7 Aug 2008
Last updated: 18 Feb 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Mower WR, Crisp JG, Krishnadasan A, Moran GJ, Abrahamian FM, Lovecchio F, Karras DJ, Steele MT, Rothman RE, Talan DA. Effect of Initial Bedside Ultrasonography on Emergency Department Skin and Soft Tissue Infection Management. Ann Emerg Med. 2019 Sep;74(3):372-380. doi: 10.1016/j.annemergmed.2019.02.002. Epub 2019 Mar 27.
PubMed 30926187
Talan DA, Moran GJ, Krishnadasan A, Abrahamian FM, Lovecchio F, Karras DJ, Steele MT, Rothman RE, Mower WR. Subgroup Analysis of Antibiotic Treatment for Skin Abscesses. Ann Emerg Med. 2018 Jan;71(1):21-30. doi: 10.1016/j.annemergmed.2017.07.483. Epub 2017 Oct 5.
PubMed 28987525
Moran GJ, Krishnadasan A, Mower WR, Abrahamian FM, LoVecchio F, Steele MT, Rothman RE, Karras DJ, Hoagland R, Pettibone S, Talan DA. Effect of Cephalexin Plus Trimethoprim-Sulfamethoxazole vs Cephalexin Alone on Clinical Cure of Uncomplicated Cellulitis: A Randomized Clinical Trial. JAMA. 2017 May 23;317(20):2088-2096. doi: 10.1001/jama.2017.5653.
PubMed 28535235
Talan DA, Lovecchio F, Abrahamian FM, Karras DJ, Steele MT, Rothman RE, Krishnadasan A, Mower WR, Hoagland R, Moran GJ. A Randomized Trial of Clindamycin Versus Trimethoprim-sulfamethoxazole for Uncomplicated Wound Infection. Clin Infect Dis. 2016 Jun 15;62(12):1505-1513. doi: 10.1093/cid/ciw177. Epub 2016 Mar 29.
PubMed 27025829
Talan DA, Mower WR, Krishnadasan A, Abrahamian FM, Lovecchio F, Karras DJ, Steele MT, Rothman RE, Hoagland R, Moran GJ. Trimethoprim-Sulfamethoxazole versus Placebo for Uncomplicated Skin Abscess. N Engl J Med. 2016 Mar 3;374(9):823-32. doi: 10.1056/NEJMoa1507476.
PubMed 26962903

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All Staphylococcal Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Strategies Using Off-Patent Antibiotics for Methicillin-Resistant Staphylococcus Aureus ("STOP MRSA") - A Phase IIB, Multi-Center, Randomized, Double-Blind Clinical Trial
ClinicalTrials.gov ID: NCT00729937
Acronym / sponsor ID: 07-0040
Conditions: Staphylococcal Infection
Keywords: Methicillin, Staphylococcus aureus, MRSA
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,265 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: Apr 2009
Primary completion: May 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 8 Aug 2008 (estimated)
Results: Posted 28 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
TMP/SMX vs. Placebo	Experimental	Other: Placebo, Drug: Trimethoprim-sulfamethoxazoleSubjects with an acute uncomplicated cutaneous abscess will be randomized to receive either Trimethoprim/Sulfamethoxazole (TMP/SMX) (4 single strength pills, 80 mg/400 mg each, twice per day) or 4 placebo pills (twice per day).
TMP/SMX vs. Clindamycin	Experimental	Drug: Clindamycin, Other: Placebo, Drug: Trimethoprim-sulfamethoxazoleSubjects with an acute uncomplicated wound infection will be randomized to receive Trimethoprim/Sulfamethoxazole (TMP/SMX) (4 single strength pills, 80 mg/400 mg each, twice per day, with alternating 1 identical placebo pill, twice per day) or clindamycin (300 mg, four times per day, with 3 placebo pills on alternating doses).
Cephalexin and TMP/SMX vs. Cephalexin	Experimental	Drug: Cephalexin, Other: Placebo, Drug: Trimethoprim-sulfamethoxazoleSubjects with acute uncomplicated cellulitis will be randomized to receive cephalexin (500 mg, four times per day) and Trimethoprim/Sulfamethoxazole (TMP/SMX) (4 single strength pills, 80 mg/400 mg each, twice per day) or cephalexin (500 mg, four times per day) and placebo (4 pills, twice per day).

Who may qualify

Ages: 13 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

Adult or child 13 years of age and older (who weighs greater than or equal to 40 kg);
Have a skin and soft tissue infection (SSTI) with all three local findings of erythema (> 2 cm across the lesion or from a discrete wound edge), tenderness, and swelling/induration. Fever, leukocytosis, and lymphangitis will be noted, but are not enrollment criteria. SSTI with these local findings will be further categorized and defined as one of:
Note: Although I\&D of an abscess is considered standard care (i.e., patients will receive I\&D whether or not they are enrolled in the study), the procedure may be performed after enrollment into the study so that prior measurements of the area of erythema and swelling/induration can be obtained unless it is an occult abscess in which the I\&D will be performed prior to enrollment to verify infection type and ensure correct classification of the subject.
Have the infected lesion for 7 days or less duration;
Are to receive outpatient treatment at enrollment/baseline;

Key exclusion criteria (27 listed)

Severe allergy or reaction to study drug or drugs similar to the study drug relevant to whichever study sub-trial the subject would be assigned to (e.g., patients with severe or life-threatening penicillin allergies, allergy to any cephalosporin, clindamycin, or sulfonamides, or any other drug containing sulfur such as thiazides, furosemide, and oral sulfonylureas);
Concomitant treatment (i.e., while on study drug therapy) with coumadin, phenytoin, or methotrexate, or suspected G-6-PD or folic acid deficiency;
Expected inability to swallow or absorb the study drug (assessed by patient history);
Pregnancy, nursing, or expectation of becoming pregnant while on study drug;
Perirectal (within 5 cm of anus), perineal non-skin lesions (i.e., mucosal), or paronychial location of infection. Scrotal and labial abscesses will not be excluded.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cephalexin500 mg, four times per day.	Drug	Cephalexin and TMP/SMX vs. Cephalexin
Clindamycin300 mg, four times per day.	Drug	TMP/SMX vs. Clindamycin
PlaceboPlacebo tablet administered orally.	Other	Cephalexin and TMP/SMX vs. Cephalexin, TMP/SMX vs. Clindamycin, TMP/SMX vs. Placebo
Trimethoprim-sulfamethoxazole4 single strength Trimethoprim/Sulfamethoxazole (TMP/SMX), 80 mg/400 mg each, twice per day.	Drug	Cephalexin and TMP/SMX vs. Cephalexin, TMP/SMX vs. Clindamycin, TMP/SMX vs. Placebo

Primary outcome

Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population
Time frame: Days 14-21
Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.

30 secondary outcomes

Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population
Time frame: Days 14-21
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
Time frame: Day 1 to Day 3-4
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
Time frame: Day 1 to Day 3-4
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
Time frame: Day 1 to Day 8-10
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
Time frame: Day 1 to Day 8-10
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
Time frame: Day 1 to Day 14-21
Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
Time frame: Day 1 to Day 14-21
Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population
Time frame: Day 14-21
Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population
Time frame: Day 14-21
Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population
Time frame: Day 1 through Day 14-21
Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population
Time frame: Day 1 through Day 14-21
Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population
Time frame: Day 1 through Day 49-63
Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population
Time frame: Day 1 through Day 49-63
Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population
Time frame: Day 1 through Day 14-21
Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population
Time frame: Day 1 through Day 14-21
Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population
Time frame: Day 1 through Day 49-63
Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population
Time frame: Day 1 through Day 49-63
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population
Time frame: Day 1 through Day 14-21
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population
Time frame: Day 1 through Day 14-21
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population
Time frame: Day 1 through Day 49-63
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population
Time frame: Day 1 through Day 49-63
Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population
Time frame: Day 1 through Day 14-21
Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population
Time frame: Day 1 through Day 14-21
Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population
Time frame: Day 1 through Day 49-63
Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population
Time frame: Day 1 through Day 49-63
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
Time frame: Day 1 through Day 49-63
Mean Days Missed From Normal Activities in the Per Protocol Population
Time frame: Day 1 through 14
Mean Days Missed From Normal Activities in the Intent to Treat Population
Time frame: Day 1 through 14
Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
Time frame: Day 1 through 14
Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
Time frame: Day 1 through 14

Results and safety

Results posted to the registry on 28 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Abscess, Placebo	629	555
Abscess, TMP/SMX	636	548
Infected Wound, TMP/SMX	251	222
Infected Wound, Clindamycin	249	215
Cellulitis, Cephalexin and TMP/SMX	249	221
Cellulitis, Cephalexin	251	214

Primary outcome: Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population

Time frame: Days 14-21. Number. Unit: participants

Measure	Abscess, Placebo n = 533	Abscess, TMP/SMX n = 524	Infected Wound, TMP/SMX n = 198	Infected Wound, Clindamycin n = 203	Cellulitis, Cephalexin and TMP/SMX n = 218	Cellulitis, Cephalexin n = 193
Clinical Cure	457	487	182	187	182	165
Clinical Failure	76	37	16	16	36	28

Population analysed: The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.

30 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Abscess, Placebo	30 of 617 (4.9%)	331 of 617 (53.6%)	Not reported
Abscess, TMP/SMX	21 of 630 (3.3%)	345 of 630 (54.8%)	Not reported
Infected Wound, TMP/SMX	15 of 250 (6%)	138 of 250 (55.2%)	Not reported
Infected Wound, Clindamycin	11 of 249 (4.4%)	127 of 249 (51%)	Not reported
Cellulitis, Cephalexin and TMP/SMX	20 of 248 (8.1%)	157 of 248 (63.3%)	Not reported
Cellulitis, Cephalexin	21 of 248 (8.5%)	149 of 248 (60.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30926187Mower WR, Crisp JG, Krishnadasan A, Moran GJ, Abrahamian FM, Lovecchio F, Karras DJ, Steele MT, Rothman RE, Talan DA. Effect of Initial Bedside Ultrasonography on Emergency Department Skin and Soft Tissue Infection Management. Ann Emerg Med. 2019 Sep;74(3):372-380. doi: 10.1016/j.annemergmed.2019.02.002. Epub 2019 Mar 27.
Derived from this study: PubMed 28987525Talan DA, Moran GJ, Krishnadasan A, Abrahamian FM, Lovecchio F, Karras DJ, Steele MT, Rothman RE, Mower WR. Subgroup Analysis of Antibiotic Treatment for Skin Abscesses. Ann Emerg Med. 2018 Jan;71(1):21-30. doi: 10.1016/j.annemergmed.2017.07.483. Epub 2017 Oct 5.
Derived from this study: PubMed 28535235Moran GJ, Krishnadasan A, Mower WR, Abrahamian FM, LoVecchio F, Steele MT, Rothman RE, Karras DJ, Hoagland R, Pettibone S, Talan DA. Effect of Cephalexin Plus Trimethoprim-Sulfamethoxazole vs Cephalexin Alone on Clinical Cure of Uncomplicated Cellulitis: A Randomized Clinical Trial. JAMA. 2017 May 23;317(20):2088-2096. doi: 10.1001/jama.2017.5653.
Derived from this study: PubMed 27025829Talan DA, Lovecchio F, Abrahamian FM, Karras DJ, Steele MT, Rothman RE, Krishnadasan A, Mower WR, Hoagland R, Moran GJ. A Randomized Trial of Clindamycin Versus Trimethoprim-sulfamethoxazole for Uncomplicated Wound Infection. Clin Infect Dis. 2016 Jun 15;62(12):1505-1513. doi: 10.1093/cid/ciw177. Epub 2016 Mar 29.
Derived from this study: PubMed 26962903Talan DA, Mower WR, Krishnadasan A, Abrahamian FM, Lovecchio F, Karras DJ, Steele MT, Rothman RE, Hoagland R, Moran GJ. Trimethoprim-Sulfamethoxazole versus Placebo for Uncomplicated Skin Abscess. N Engl J Med. 2016 Mar 3;374(9):823-32. doi: 10.1056/NEJMoa1507476.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population (time frame: Days 14-21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00729937, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2015.