Skin Disease, BacterialNCT02024867
Evaluation of 3 Versus 10 Days of Antibiotics in Skin Abscesses After Surgical Drainage
A study testing Trimethoprim-Sulfamethoxazole in people with Skin Disease, Bacterial and Abscess, run by Lucy Holmes, MD at 1 site in United States.
Trial summary
The objective of this study is to determine if there is a difference in treatment failures and recurrent skin infections when patients are given 3 or 10 days of antibiotics for uncomplicated skin abscesses after they have been surgically drained. Read more about this study
- Who is it for?
- Ages 3 months to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Disease, Bacterial, Abscess
- What is being tested?
- Trimethoprim-Sulfamethoxazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jul 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
- patients presenting with a skin abscess that requires surgical drainage (induration ≥ 1 cm in diameter)
- minimally invasive surgical technique with the insertion of a subcutaneous drain can be utilized on the patient
Who cannot join
- patients requiring immediate hospitalization
- patients who have received 2 or more doses of antibiotics in the previous 36 hours
- patients with diabetes, sickle-cell disease, an immuno-compromising disease, an underlying medical condition predisposing the patient to frequent hospitalizations or medical visits, or indwelling catheters or percutaneous medical devices
- patients with a concurrent, non-abscess infection
- patients with an allergy to Trimethoprim-sulfamethoxazole
Trial locations and contacts
1 site in 1 country.
United States1 site
Women & Children's Hospital of Buffalo
Buffalo, New York, 14222
About this study
Official title: Randomized Non-inferiority Trial of 3 Versus 10 Days of Trimethoprim-Sulfamethoxazole in Community-Associated Skin Abscesses After Surgical Drainage
The objective of this study is to determine if there is a difference in treatment failures and recurrent skin infections when patients are given 3 or 10 days of antibiotics for uncomplicated skin abscesses after they have been surgically drained.
Read the detailed description
Patients age 3 months to 17 years presenting to a pediatric Emergency Department (ED) with an uncomplicated skin abscess that required surgical drainage were randomized to receive 3 or 10 days of oral trimethoprim-sulfamethoxazole. Patients were evaluated 10 to 14 days later to assess for cure. Patients were contacted 1 month later to determine if they had developed another skin infection. Outcomes were also stratified by methicillin-resistent staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus aureus (MSSA).
- Conditions
- Skin Disease, Bacterial, Abscess
- Being tested
- Trimethoprim-Sulfamethoxazole
- Keywords
- Methicillin resistent Staphylococcus aureus, Staphylococcus aureus
- Medical subject headings
- Skin Diseases, Bacterial, Abscess, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimethoprim-SulfamethoxazoleDrug
Also called Septra, Bactrim
3 versus 10 days of drug
| Study group | Role | What they receive |
|---|---|---|
| 10 days of Trimethoprim-Sulfamethoxazole | Active comparator | Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day Receives: Drug: Trimethoprim-Sulfamethoxazole |
| 3 days of Trimethoprim-Sulfamethoxazole | Experimental | Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day Receives: Drug: Trimethoprim-Sulfamethoxazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Failures
Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.
Measured: up to 2 weeks after surgical drainage
Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus
Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.
Measured: up to 2 weeks after surgical drainage
Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus
Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.
Measured: up to 2 weeks after surgical drainage
Secondary outcomes (3)
Recurrent Skin Infections
Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.
Measured: 1 month after surgical drainage
Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus
Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.
Measured: 1 month after surgical drainage
Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus
Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.
Measured: 1 month after surgical drainage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startFeb 2010
- Primary completionJan 2012
- Study completionJul 2012
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 (3)Papers the sponsor has linked to this study.
- Other trials for Skin Disease, BacterialStudies 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
- None (open label)
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lucy Holmes, MD
- Sponsor type
- University, hospital or other
- Collaborators
- New York State Department of Health, Women & Children's Hospital of Buffalo
- Responsible party
- Sponsor-investigator, Lucy Holmes, MD, State University of New York at Buffalo
- Investigators
- Lucy C Holmes, MD, Principal investigator, University at BuffaloHoward Faden, MD, Study chair, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024867
- Sponsor's protocol ID
- DB 2456
- Status last verified
- Sep 2015
- First submitted
- 26 Dec 2013
- Last updated
- 19 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Duong M, Markwell S, Peter J, Barenkamp S. Randomized, controlled trial of antibiotics in the management of community-acquired skin abscesses in the pediatric patient. Ann Emerg Med. 2010 May;55(5):401-7. doi: 10.1016/j.annemergmed.2009.03.014. Epub 2009 May 5.
PubMed 19409657Schmitz GR, Bruner D, Pitotti R, Olderog C, Livengood T, Williams J, Huebner K, Lightfoot J, Ritz B, Bates C, Schmitz M, Mete M, Deye G. Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection. Ann Emerg Med. 2010 Sep;56(3):283-7. doi: 10.1016/j.annemergmed.2010.03.002. Epub 2010 Mar 26.
PubMed 20346539Holmes L, Ma C, Qiao H, Drabik C, Hurley C, Jones D, Judkiewicz S, Faden H. Trimethoprim-Sulfamethoxazole Therapy Reduces Failure and Recurrence in Methicillin-Resistant Staphylococcus aureus Skin Abscesses after Surgical Drainage. J Pediatr. 2016 Feb;169:128-34.e1. doi: 10.1016/j.jpeds.2015.10.044. Epub 2015 Nov 11.
PubMed 26578074
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Non-inferiority Trial of 3 Versus 10 Days of Trimethoprim-Sulfamethoxazole in Community-Associated Skin Abscesses After Surgical Drainage
- ClinicalTrials.gov ID
- NCT02024867
- Acronym / sponsor ID
- DB 2456
- Conditions
- Skin Disease, Bacterial, Abscess
- Keywords
- Methicillin resistent Staphylococcus aureus, Staphylococcus aureus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Lucy Holmes, MDUniversity, hospital or other
- Collaborators
- New York State Department of Health, Women & Children's Hospital of Buffalo
- Study start
- Feb 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Posted 15 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine if there is a difference in treatment failures and recurrent skin infections when patients are given 3 or 10 days of antibiotics for uncomplicated skin abscesses after they have been surgically drained.
Detailed description
Patients age 3 months to 17 years presenting to a pediatric Emergency Department (ED) with an uncomplicated skin abscess that required surgical drainage were randomized to receive 3 or 10 days of oral trimethoprim-sulfamethoxazole. Patients were evaluated 10 to 14 days later to assess for cure. Patients were contacted 1 month later to determine if they had developed another skin infection. Outcomes were also stratified by methicillin-resistent staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus aureus (MSSA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 days of Trimethoprim-Sulfamethoxazole | Active comparator | Drug: Trimethoprim-SulfamethoxazoleOral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day |
| 3 days of Trimethoprim-Sulfamethoxazole | Experimental | Drug: Trimethoprim-SulfamethoxazoleOral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day |
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- patients presenting with a skin abscess that requires surgical drainage (induration ≥ 1 cm in diameter)
- minimally invasive surgical technique with the insertion of a subcutaneous drain can be utilized on the patient
Key exclusion criteria (5 listed)
- patients requiring immediate hospitalization
- patients who have received 2 or more doses of antibiotics in the previous 36 hours
- patients with diabetes, sickle-cell disease, an immuno-compromising disease, an underlying medical condition predisposing the patient to frequent hospitalizations or medical visits, or indwelling catheters or percutaneous medical devices
- patients with a concurrent, non-abscess infection
- patients with an allergy to Trimethoprim-sulfamethoxazole
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: Septra, Bactrim3 versus 10 days of drug | Drug | 10 days of Trimethoprim-Sulfamethoxazole, 3 days of Trimethoprim-Sulfamethoxazole |
Primary outcome
Treatment Failures
Time frame: up to 2 weeks after surgical drainage
Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.
Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus
Time frame: up to 2 weeks after surgical drainage
Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.
Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus
Time frame: up to 2 weeks after surgical drainage
Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.
3 secondary outcomes
Recurrent Skin Infections
Time frame: 1 month after surgical drainage
Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus
Time frame: 1 month after surgical drainage
Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus
Time frame: 1 month after surgical drainage
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19409657Duong M, Markwell S, Peter J, Barenkamp S. Randomized, controlled trial of antibiotics in the management of community-acquired skin abscesses in the pediatric patient. Ann Emerg Med. 2010 May;55(5):401-7. doi: 10.1016/j.annemergmed.2009.03.014. Epub 2009 May 5.
- Background: PubMed 20346539Schmitz GR, Bruner D, Pitotti R, Olderog C, Livengood T, Williams J, Huebner K, Lightfoot J, Ritz B, Bates C, Schmitz M, Mete M, Deye G. Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection. Ann Emerg Med. 2010 Sep;56(3):283-7. doi: 10.1016/j.annemergmed.2010.03.002. Epub 2010 Mar 26.
- Derived from this study: PubMed 26578074Holmes L, Ma C, Qiao H, Drabik C, Hurley C, Jones D, Judkiewicz S, Faden H. Trimethoprim-Sulfamethoxazole Therapy Reduces Failure and Recurrence in Methicillin-Resistant Staphylococcus aureus Skin Abscesses after Surgical Drainage. J Pediatr. 2016 Feb;169:128-34.e1. doi: 10.1016/j.jpeds.2015.10.044. Epub 2015 Nov 11.
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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.
Lucy C Holmes, MD principal investigator
University at Buffalo
Howard Faden, MD study chair
University at Buffalo
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 in people with Skin Disease, Bacterial and Abscess, run by Lucy Holmes, MD 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 2 inclusion and 5 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 19 Oct 2015. 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. 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 15 Sep 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?
Treatment Failures (time frame: up to 2 weeks after surgical drainage). The study lists 3 primary outcomes in all. 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 NCT02024867, which also lists 3 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 19 Oct 2015.