Skin Diseases, InfectiousPhase 4NCT02582203
Clinical and Economic Outcomes of Ceftaroline Fosamil for ABSSSI Documented or at Risk of MRSA
A Phase 4 study testing Ceftaroline and Vancomycin in people with Skin Diseases, Infectious and Staphylococcal Skin Infections, run by Wayne State University at 3 sites in United States.
Trial summary
The proposed study is a prospective, open-label, randomized, multi-center trial of ceftaroline versus vancomycin for the treatment of ABSSSI in patients documented or at risk for MRSA. Patients admitted to the Detroit Medical Center, Henry Ford Hospital, or St. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Diseases, Infectious, Staphylococcal Skin Infections
- What is being tested?
- Ceftaroline and Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2012to May 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Acute bacterial skin and skin structure infection (cellulitis, major abscess, surgical site infection)
- Presence of MRSA or documented risk factors for MRSA (prior antibiotic use 60 days, prior hospital exposure 180 days, skin ulcers, central venous catheter)
- Anticipating no less than two days of hospital admission
- Signed informed consent
Who cannot join
- Gas gangrene/progressive necrotizing infections
- Osteomyelitis
- Infections due to Gram-negative pathogens or other Gram-positive pathogens if S. aureus or Streptococcus is not present
- Pathogens known at the study entry to be resistant to ceftaroline or vancomycin
- Anticipated to require non-study antibiotic active against S. aureus for another reason
- Treatment for the current episode of ABSSSI for > 24 hours with another intravenous anti-MRSA antibiotic
Show all 12Show fewer
- Surgical (I \& D) as definitive/curative treatment
- Presence of prosthetic hardware or invasive devices suspected to be the source of infection but cannot be removed
- Life expectancy < 2 months
- Open burn wound > 30% total body surface area
- Pregnant or nursing mothers
- Known allergic reaction to vancomycin or ceftaroline
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Detroit Medical Center
Detroit, Michigan, 48201
St. John Hospital and Medical Center
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
About this study
Official title: Clinical and Economic Outcomes of Ceftaroline Fosamil for the Treatment of Acute Bacterial Skin and Skin Structure Infections Documented or at Risk of Methicillin-Resistant S. Aureus
The proposed study is a prospective, open-label, randomized, multi-center trial of ceftaroline versus vancomycin for the treatment of ABSSSI in patients documented or at risk for MRSA. Patients admitted to the Detroit Medical Center, Henry Ford Hospital, or St. John Medical Center in Detroit Michigan with a documented ABSSSI between April 2012 and November 2015 will be evaluated for inclusion. Patients must present with at least 3 of the following local signs/symptoms: pain, tenderness, swelling erythema, warmth, drainage/discharge, induration, and lymph node swelling/tenderness. Patients will be randomized 1:1 ceftaroline or vancomycin with optional anaerobic and/or Gram-negative coverage. The assignment of study drug will follow a randomized list that was previously generated via a computerized random mix block generator (nQuery Advisor® 7.0) and available at each of the study sites. Patients will be randomized to ceftaroline intravenously at 600 mg infused over 1 hour every 12 hours for patients with normal renal function. Patients randomized to vancomycin will receive the standard 15 mg/kg dose based on total body weight infused over 1 hour q 12 hour, dose and interval adjusted based on creatinine clearance and via institution-specific pharmacy protocol to target serum trough concentrations of 10-20 mg/L within the first 72 hours. Outcomes measured in the Clinically Evaluable patient population include day two or three size reduction (percentage) and clinical response at end of therapy or discharge.
- Being tested
- Ceftaroline, Vancomycin
- Keywords
- Ceftaroline fosamil, Vancomycin, Acute bacterial skin and skin structure infections, Methicillin-resistant S. aureus
- Medical subject headings
- Skin Diseases, Infectious, Staphylococcal Skin Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftarolineDrug
VancomycinDrug
| Study group | Role | What they receive |
|---|---|---|
| Ceftaroline | Active comparator | 600 mg IV (over 1 hour) every 12 hours for renal function > 50 mL/min, adjusted for renal function based on package insert for no more than 14 days. Receives: Drug: Ceftaroline |
| Vancomycin | Active comparator | Dosed by institutional pharmacy protocol to reach goal trough level of 10 - 20 mg/L steady state concentration for no more than 14 days. Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Clinical Response
Reduction of lesion size from baseline of at least 20%
Measured: 48 to 72 hours after initiation of study drug
Secondary outcomes (2)
Overall Clinical Response
Cure: pretreatment signs and symptoms are improved or resolved and no additional antibiotic therapy is necessary
- Improved: pretreatment signs and symptoms are improved and additional antibiotic therapy is necessary
- Failure: Persistent, worsening, or new/recurrent signs and symptoms, antibiotics needed > 14 days, or the need for a change in antibiotic therapy
Measured: End or therapy or patient discharge [Up to 60 days]
Length of stay
Total duration of hospitalization
Measured: During hospitalization [Up to 60 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startFeb 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin Diseases, InfectiousStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- Henry Ford Hospital, St. John Providence Health System, Detroit Medical Center, Forest Laboratories
- Responsible party
- Principal investigator, Michael J. Rybak, Wayne State University
- Investigators
- Michael Rybak, PharmD, MPH, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582203
- Sponsor's protocol ID
- 1111010324
- Status last verified
- Oct 2016
- First submitted
- 16 Oct 2015
- Last updated
- 1 Nov 2016
- Results posted
- No
Publications
Claeys KC, Zasowski EJ, Trinh TD, Casapao AM, Pogue JM, Bhatia N, Mynatt RP, Wilson SS, Arthur C, Welch R, Sherwin R, Hafeez W, Levine DP, Kaye KS, Delgado G, Giuliano CA, Takla R, Rieck C, Johnson LB, Murray KP, Gordon J, Reyes K, Hartman P, Davis SL, Rybak MJ. Open-Label Randomized Trial of Early Clinical Outcomes of Ceftaroline Fosamil Versus Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections at Risk of Methicillin-Resistant Staphylococcus aureus. Infect Dis Ther. 2019 Jun;8(2):199-208. doi: 10.1007/s40121-019-0242-5. Epub 2019 Mar 27.
PubMed 30915685
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economic Outcomes of Ceftaroline Fosamil for the Treatment of Acute Bacterial Skin and Skin Structure Infections Documented or at Risk of Methicillin-Resistant S. Aureus
- ClinicalTrials.gov ID
- NCT02582203
- Acronym / sponsor ID
- 1111010324
- Keywords
- Ceftaroline fosamil, Vancomycin, Acute bacterial skin and skin structure infections, Methicillin-resistant S. aureus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- Henry Ford Hospital, St. John Providence Health System, Detroit Medical Center, Forest Laboratories
- Study start
- Feb 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is a prospective, open-label, randomized, multi-center trial of ceftaroline versus vancomycin for the treatment of ABSSSI in patients documented or at risk for MRSA. Patients admitted to the Detroit Medical Center, Henry Ford Hospital, or St. John Medical Center in Detroit Michigan with a documented ABSSSI between April 2012 and November 2015 will be evaluated for inclusion. Patients must present with at least 3 of the following local signs/symptoms: pain, tenderness, swelling erythema, warmth, drainage/discharge, induration, and lymph node swelling/tenderness. Patients will be randomized 1:1 ceftaroline or vancomycin with optional anaerobic and/or Gram-negative coverage. The assignment of study drug will follow a randomized list that was previously generated via a computerized random mix block generator (nQuery Advisor® 7.0) and available at each of the study sites. Patients will be randomized to ceftaroline intravenously at 600 mg infused over 1 hour every 12 hours for patients with normal renal function. Patients randomized to vancomycin will receive the standard 15 mg/kg dose based on total body weight infused over 1 hour q 12 hour, dose and interval adjusted based on creatinine clearance and via institution-specific pharmacy protocol to target serum trough concentrations of 10-20 mg/L within the first 72 hours. Outcomes measured in the Clinically Evaluable patient population include day two or three size reduction (percentage) and clinical response at end of therapy or discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceftaroline | Active comparator | Drug: Ceftaroline600 mg IV (over 1 hour) every 12 hours for renal function > 50 mL/min, adjusted for renal function based on package insert for no more than 14 days. |
| Vancomycin | Active comparator | Drug: VancomycinDosed by institutional pharmacy protocol to reach goal trough level of 10 - 20 mg/L steady state concentration for no more than 14 days. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute bacterial skin and skin structure infection (cellulitis, major abscess, surgical site infection)
- Presence of MRSA or documented risk factors for MRSA (prior antibiotic use 60 days, prior hospital exposure 180 days, skin ulcers, central venous catheter)
- Anticipating no less than two days of hospital admission
- Signed informed consent
Key exclusion criteria (12 listed)
- Gas gangrene/progressive necrotizing infections
- Osteomyelitis
- Infections due to Gram-negative pathogens or other Gram-positive pathogens if S. aureus or Streptococcus is not present
- Pathogens known at the study entry to be resistant to ceftaroline or vancomycin
- Anticipated to require non-study antibiotic active against S. aureus for another reason
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 |
|---|---|---|
| Ceftaroline | Drug | Ceftaroline |
| Vancomycin | Drug | Vancomycin |
Primary outcome
Early Clinical Response
Time frame: 48 to 72 hours after initiation of study drug
Reduction of lesion size from baseline of at least 20%
2 secondary outcomes
Overall Clinical Response
Time frame: End or therapy or patient discharge [Up to 60 days]
Length of stay
Time frame: During hospitalization [Up to 60 days]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Derived from this study: PubMed 30915685Claeys KC, Zasowski EJ, Trinh TD, Casapao AM, Pogue JM, Bhatia N, Mynatt RP, Wilson SS, Arthur C, Welch R, Sherwin R, Hafeez W, Levine DP, Kaye KS, Delgado G, Giuliano CA, Takla R, Rieck C, Johnson LB, Murray KP, Gordon J, Reyes K, Hartman P, Davis SL, Rybak MJ. Open-Label Randomized Trial of Early Clinical Outcomes of Ceftaroline Fosamil Versus Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections at Risk of Methicillin-Resistant Staphylococcus aureus. Infect Dis Ther. 2019 Jun;8(2):199-208. doi: 10.1007/s40121-019-0242-5. Epub 2019 Mar 27.
Related trials for Skin Diseases, Infectious
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
RecruitingObservational study
Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia
Idiopathic CD4+ Lymphocytopenia, Cryptococcal Meningitis
Not yet recruitingPhase 4
Comparative Efficacy of Luliconazole and Bifonazole Combined With Itraconazole in Dermatophytosis
Tinea Corporis,Tinea Cruris,Tinea Faciei
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.
Michael Rybak, PharmD, MPH principal investigator
Wayne State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ceftaroline and Vancomycin in people with Skin Diseases, Infectious and Staphylococcal Skin Infections, run by Wayne State University at 3 sites in United States.
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 4 inclusion and 12 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 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Early Clinical Response (time frame: 48 to 72 hours after initiation of study drug). 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 NCT02582203, which also lists 1 linked publication.
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 1 Nov 2016.