AbscessNCT00822692
Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection
A study testing Trim/ Sulfa DS in people with Abscess and Methicillin-Resistant Staphylococcus Aureus Infection, run by 59th Medical Wing at 1 site in United States.
Trial summary
Patients will be enrolled in a multi-center study (Wilford Hall Medical Center and Brooke Army Medical Center) to prospectively evaluate outcome after treatment for an uncomplicated skin abscess. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Abscess, Methicillin-Resistant Staphylococcus Aureus Infection
- What is being tested?
- Trim/ Sulfa DS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jun 2009
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients age 18-65 who present to the emergency department with a skin abscess that requires incision and drainage.
Who cannot join
- Patients with diabetes, HIV, cancer or other immunocompromised patients.
- Additionally, any patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables.
- Pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment.
- Patients with abscesses on head, face, perirectal, or periananal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded.
- Finally, patients with sulfa allergy will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236
About this study
Official title: Prospective Randomized Double Blind, Placebo-Controlled Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection on 30 Day Recurrence Rates.
Patients will be enrolled in a multi-center study (Wilford Hall Medical Center and Brooke Army Medical Center) to prospectively evaluate outcome after treatment for an uncomplicated skin abscess.
Read the detailed description
All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1) septa double strength two pills orally twice a day x 7 days or 2)placebo. Patients will then return to the emergency room on days 3 and 7 for wound repacking and evaluation. The primary outcome recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics if needed. Data will be analyzed both by initial randomization and intention to treat.
- Being tested
- Trim/ Sulfa DS, placebo
- Keywords
- Abscess, Cellulitis, Antibiotics, MRSA
- Medical subject headings
- Abscess, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trim/ Sulfa DSDrug
Also called Bactrim
bactrim DS (800/160) two tablets PO BID x 7 days
placeboDrug
matched placebo 2 pills PO BID x 7 days
| Study group | Role | What they receive |
|---|---|---|
| Bactrim DS | Active comparator | Trim/sulfa (800/160) two tablets orally (PO) twice a day (BID) x 7 days Receives: Drug: Trim/ Sulfa DS |
| matched placebo | Placebo comparator | matched placebo 2 pills orally (PO) twice a day (BID) x 7 days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Rates of Abscesses
Number of patient with a new abscess in same or different location as previous lesion
Measured: 30 days after incision and drainage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startJul 2008
- Primary completionJun 2009
- Study completionJun 2009
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 (1)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
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- 59th Medical Wing
- Sponsor type
- US federal agency
- Collaborators
- U.S. Air Force Office of the Surgeon General, Emergency Medicine Foundation
- Responsible party
- Principal investigator, Gillian Schmitz, 59th Medical Wing
- Investigators
- Gillian R Schmitz, Principal investigator, 59th Medical Wing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822692
- Sponsor's protocol ID
- FWH20080055H
- Status last verified
- Dec 2015
- First submitted
- 13 Jan 2009
- Last updated
- 21 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Schmitz 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 20346539
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Double Blind, Placebo-Controlled Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection on 30 Day Recurrence Rates.
- ClinicalTrials.gov ID
- NCT00822692
- Acronym / sponsor ID
- FWH20080055H
- Keywords
- Abscess, Cellulitis, Antibiotics, MRSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- 59th Medical WingUS federal agency
- Collaborators
- U.S. Air Force Office of the Surgeon General, Emergency Medicine Foundation
- Study start
- Jul 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Jan 2009 (estimated)
- Results
- Posted 3 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will be enrolled in a multi-center study (Wilford Hall Medical Center and Brooke Army Medical Center) to prospectively evaluate outcome after treatment for an uncomplicated skin abscess.
Detailed description
All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1) septa double strength two pills orally twice a day x 7 days or 2)placebo. Patients will then return to the emergency room on days 3 and 7 for wound repacking and evaluation. The primary outcome recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics if needed. Data will be analyzed both by initial randomization and intention to treat.
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 |
|---|---|---|
| Bactrim DS | Active comparator | Drug: Trim/ Sulfa DSTrim/sulfa (800/160) two tablets orally (PO) twice a day (BID) x 7 days |
| matched placebo | Placebo comparator | Drug: placebomatched placebo 2 pills orally (PO) twice a day (BID) x 7 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients age 18-65 who present to the emergency department with a skin abscess that requires incision and drainage.
Key exclusion criteria (5 listed)
- Patients with diabetes, HIV, cancer or other immunocompromised patients.
- Additionally, any patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables.
- Pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment.
- Patients with abscesses on head, face, perirectal, or periananal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded.
- Finally, patients with sulfa allergy will 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 |
|---|---|---|
| Trim/ Sulfa DSAlso: Bactrimbactrim DS (800/160) two tablets PO BID x 7 days | Drug | Bactrim DS |
| placebomatched placebo 2 pills PO BID x 7 days | Drug | matched placebo |
Primary outcome
Recurrence Rates of Abscesses
Time frame: 30 days after incision and drainage
Number of patient with a new abscess in same or different location as previous lesion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: 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.
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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.
Gillian R Schmitz principal investigator
59th Medical Wing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trim/ Sulfa DS in people with Abscess and Methicillin-Resistant Staphylococcus Aureus Infection, run by 59th Medical Wing 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 1 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 21 Dec 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. 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 3 Sep 2009). 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?
Recurrence Rates of Abscesses (time frame: 30 days after incision and drainage). 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 NCT00822692, 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 21 Dec 2015.