AbscessNCT00867789
Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department
A study testing Trimethoprim-sulfamethoxazole and Sugar pill in people with Abscess, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The purpose of this study is to determine if there is a difference between an antibiotic, trimethoprim-sulfamethoxazole versus placebo in healing outcomes of soft tissue abscesses following incision and drainage. Read more about this study
- Who is it for?
- Ages 3 months to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Abscess
- What is being tested?
- Trimethoprim-sulfamethoxazole and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Oct 2012
- Phase
- Interventional
- 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 3 months to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 3 months to 17 years
- Single, localized soft tissue abscesses requiring incision and drainage with purulent material obtained
- Diameter of the abscess less than 5cm as measured by the treating physician
Who cannot join
- Signs of systemic illness or ill-appearing, as determined by the treating physician
- Admission to the hospital following treatment in the Emergency Department
- Known sulfa allergy
- Immunocompromised patients
- Soft tissue abscesses involving the perineum (labia, scrotum, penis, perirectal)
- Previous antibiotic use (for any reason) in the past seven days
- Non-English speaking patients and families
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
About this study
Official title: Trimethoprim-sulfamethoxazole Versus Placebo in the Treatment of Cutaneous Abscesses in the Emergency Department
The purpose of this study is to determine if there is a difference between an antibiotic, trimethoprim-sulfamethoxazole versus placebo in healing outcomes of soft tissue abscesses following incision and drainage.
- Conditions
- Abscess
- Being tested
- Trimethoprim-sulfamethoxazole, Sugar pill
- Keywords
- abscess, outcomes, antibiotics, incision and drainage, skin abscess
- Medical subject headings
- Abscess, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimethoprim-sulfamethoxazoleDrug
Also called Bactrim
10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)
Sugar pillDrug
10mg/kg/day divided twice daily for ten days. Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder.
| Study group | Role | What they receive |
|---|---|---|
| Trimethoprim-sulfamethaxazole | Experimental | Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients) Receives: Drug: Trimethoprim-sulfamethoxazole |
| Sugar pill | Placebo comparator | Incision and drainage of the abscess and treatment with oral placebo (100 patients) Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Outcomes After Use With Trimethoprim-sulfamethaxazole
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Slow enrollment due to subjects not meeting inclusion/exclusion criteria
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 (18)Papers the sponsor has linked to this study.
- Other trials for AbscessStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield
- Responsible party
- Sponsor
- Investigators
- Joan E Giovanni, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867789
- Sponsor's protocol ID
- 0810-162
- Status last verified
- Jan 2021
- First submitted
- 23 Mar 2009
- Last updated
- 26 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McCaig LF, McDonald LC, Mandal S, Jernigan DB. Staphylococcus aureus-associated skin and soft tissue infections in ambulatory care. Emerg Infect Dis. 2006 Nov;12(11):1715-23. doi: 10.3201/eid1211.060190.
PubMed 17283622Halvorson GD, Halvorson JE, Iserson KV. Abscess incision and drainage in the emergency department--Part I. J Emerg Med. 1985;3(3):227-32. doi: 10.1016/0736-4679(85)90077-0.
PubMed 4093575Meislin HW, McGehee MD, Rosen P. Management and microbiology of cutaneous abscesses. JACEP. 1978 May;7(5):186-91. doi: 10.1016/s0361-1124(78)80097-5.
PubMed 349218Macfie J, Harvey J. The treatment of acute superficial abscesses: a prospective clinical trial. Br J Surg. 1977 Apr;64(4):264-6. doi: 10.1002/bjs.1800640410.
PubMed 322789Burney RE. Incision and drainage procedures: soft tissue abscesses in the emergency service. Emerg Med Clin North Am. 1986 Aug;4(3):527-42. No abstract available.
PubMed 3720656Llera JL, Levy RC, Staneck JL. Cutaneous abscesses: natural history and management in an outpatient facility. J Emerg Med. 1984;1(6):489-93. doi: 10.1016/0736-4679(84)90002-7.
PubMed 6444142Llera JL, Levy RC. Treatment of cutaneous abscess: a double-blind clinical study. Ann Emerg Med. 1985 Jan;14(1):15-9. doi: 10.1016/s0196-0644(85)80727-7.
PubMed 3880635Frank AL, Marcinak JF, Mangat PD, Tjhio JT, Kelkar S, Schreckenberger PC, Quinn JP. Clindamycin treatment of methicillin-resistant Staphylococcus aureus infections in children. Pediatr Infect Dis J. 2002 Jun;21(6):530-4. doi: 10.1097/00006454-200206000-00010.
PubMed 12182377Frank AL, Marcinak JF, Mangat PD, Schreckenberger PC. Community-acquired and clindamycin-susceptible methicillin-resistant Staphylococcus aureus in children. Pediatr Infect Dis J. 1999 Nov;18(11):993-1000. doi: 10.1097/00006454-199911000-00012.
PubMed 10571437Frazee BW, Lynn J, Charlebois ED, Lambert L, Lowery D, Perdreau-Remington F. High prevalence of methicillin-resistant Staphylococcus aureus in emergency department skin and soft tissue infections. Ann Emerg Med. 2005 Mar;45(3):311-20. doi: 10.1016/j.annemergmed.2004.10.011.
PubMed 15726056Mishaan AM, Mason EO Jr, Martinez-Aguilar G, Hammerman W, Propst JJ, Lupski JR, Stankiewicz P, Kaplan SL, Hulten K. Emergence of a predominant clone of community-acquired Staphylococcus aureus among children in Houston, Texas. Pediatr Infect Dis J. 2005 Mar;24(3):201-6. doi: 10.1097/01.inf.0000151107.29132.70.
PubMed 15750454Fergie JE, Purcell K. Community-acquired methicillin-resistant Staphylococcus aureus infections in south Texas children. Pediatr Infect Dis J. 2001 Sep;20(9):860-3. doi: 10.1097/00006454-200109000-00007.
PubMed 11734764Sattler CA, Mason EO Jr, Kaplan SL. Prospective comparison of risk factors and demographic and clinical characteristics of community-acquired, methicillin-resistant versus methicillin-susceptible Staphylococcus aureus infection in children. Pediatr Infect Dis J. 2002 Oct;21(10):910-7. doi: 10.1097/00006454-200210000-00005.
PubMed 12394811Purcell K, Fergie J. Epidemic of community-acquired methicillin-resistant Staphylococcus aureus infections: a 14-year study at Driscoll Children's Hospital. Arch Pediatr Adolesc Med. 2005 Oct;159(10):980-5. doi: 10.1001/archpedi.159.10.980.
PubMed 16203945Kaplan SL. Treatment of community-associated methicillin-resistant Staphylococcus aureus infections. Pediatr Infect Dis J. 2005 May;24(5):457-8. doi: 10.1097/01.inf.0000164162.00163.9d. No abstract available.
PubMed 15876948
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trimethoprim-sulfamethoxazole Versus Placebo in the Treatment of Cutaneous Abscesses in the Emergency Department
- ClinicalTrials.gov ID
- NCT00867789
- Acronym / sponsor ID
- 0810-162
- Conditions
- Abscess
- Keywords
- abscess, outcomes, antibiotics, incision and drainage, skin abscess
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment due to subjects not meeting inclusion/exclusion criteria
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield
- Study start
- Mar 2009 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 24 Mar 2009 (estimated)
- Results
- Posted 26 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if there is a difference between an antibiotic, trimethoprim-sulfamethoxazole versus placebo in healing outcomes of soft tissue abscesses following incision and drainage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trimethoprim-sulfamethaxazole | Experimental | Drug: Trimethoprim-sulfamethoxazoleIncision and drainage of the abscess and treatment with oral TMP-SMX (100 patients) |
| Sugar pill | Placebo comparator | Drug: Sugar pillIncision and drainage of the abscess and treatment with oral placebo (100 patients) |
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 3 months to 17 years
- Single, localized soft tissue abscesses requiring incision and drainage with purulent material obtained
- Diameter of the abscess less than 5cm as measured by the treating physician
Key exclusion criteria (7 listed)
- Signs of systemic illness or ill-appearing, as determined by the treating physician
- Admission to the hospital following treatment in the Emergency Department
- Known sulfa allergy
- Immunocompromised patients
- Soft tissue abscesses involving the perineum (labia, scrotum, penis, perirectal)
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 |
|---|---|---|
| Trimethoprim-sulfamethoxazoleAlso: Bactrim10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose) | Drug | Trimethoprim-sulfamethaxazole |
| Sugar pill10mg/kg/day divided twice daily for ten days. Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder. | Drug | Sugar pill |
Primary outcome
Health Outcomes After Use With Trimethoprim-sulfamethaxazole
Time frame: two years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17283622McCaig LF, McDonald LC, Mandal S, Jernigan DB. Staphylococcus aureus-associated skin and soft tissue infections in ambulatory care. Emerg Infect Dis. 2006 Nov;12(11):1715-23. doi: 10.3201/eid1211.060190.
- Background: PubMed 4093575Halvorson GD, Halvorson JE, Iserson KV. Abscess incision and drainage in the emergency department--Part I. J Emerg Med. 1985;3(3):227-32. doi: 10.1016/0736-4679(85)90077-0.
- Background: PubMed 349218Meislin HW, McGehee MD, Rosen P. Management and microbiology of cutaneous abscesses. JACEP. 1978 May;7(5):186-91. doi: 10.1016/s0361-1124(78)80097-5.
- Background: PubMed 322789Macfie J, Harvey J. The treatment of acute superficial abscesses: a prospective clinical trial. Br J Surg. 1977 Apr;64(4):264-6. doi: 10.1002/bjs.1800640410.
- Background: PubMed 3720656Burney RE. Incision and drainage procedures: soft tissue abscesses in the emergency service. Emerg Med Clin North Am. 1986 Aug;4(3):527-42. No abstract available.
- Background: PubMed 6444142Llera JL, Levy RC, Staneck JL. Cutaneous abscesses: natural history and management in an outpatient facility. J Emerg Med. 1984;1(6):489-93. doi: 10.1016/0736-4679(84)90002-7.
- Background: PubMed 3880635Llera JL, Levy RC. Treatment of cutaneous abscess: a double-blind clinical study. Ann Emerg Med. 1985 Jan;14(1):15-9. doi: 10.1016/s0196-0644(85)80727-7.
- Background: PubMed 12182377Frank AL, Marcinak JF, Mangat PD, Tjhio JT, Kelkar S, Schreckenberger PC, Quinn JP. Clindamycin treatment of methicillin-resistant Staphylococcus aureus infections in children. Pediatr Infect Dis J. 2002 Jun;21(6):530-4. doi: 10.1097/00006454-200206000-00010.
- Background: PubMed 10571437Frank AL, Marcinak JF, Mangat PD, Schreckenberger PC. Community-acquired and clindamycin-susceptible methicillin-resistant Staphylococcus aureus in children. Pediatr Infect Dis J. 1999 Nov;18(11):993-1000. doi: 10.1097/00006454-199911000-00012.
- Background: PubMed 15726056Frazee BW, Lynn J, Charlebois ED, Lambert L, Lowery D, Perdreau-Remington F. High prevalence of methicillin-resistant Staphylococcus aureus in emergency department skin and soft tissue infections. Ann Emerg Med. 2005 Mar;45(3):311-20. doi: 10.1016/j.annemergmed.2004.10.011.
- Background: PubMed 15750454Mishaan AM, Mason EO Jr, Martinez-Aguilar G, Hammerman W, Propst JJ, Lupski JR, Stankiewicz P, Kaplan SL, Hulten K. Emergence of a predominant clone of community-acquired Staphylococcus aureus among children in Houston, Texas. Pediatr Infect Dis J. 2005 Mar;24(3):201-6. doi: 10.1097/01.inf.0000151107.29132.70.
- Background: PubMed 11734764Fergie JE, Purcell K. Community-acquired methicillin-resistant Staphylococcus aureus infections in south Texas children. Pediatr Infect Dis J. 2001 Sep;20(9):860-3. doi: 10.1097/00006454-200109000-00007.
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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.
Joan E Giovanni, MD principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trimethoprim-sulfamethoxazole and Sugar pill in people with Abscess, run by Children's Mercy Hospital Kansas City at 1 site 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2021). 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?
Health Outcomes After Use With Trimethoprim-sulfamethaxazole (time frame: two years). 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 NCT00867789, which also lists 18 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 26 Jan 2021.