AbscessNCT00829686
Trial of Antibiotic Treatment for Skin Abscess in Patients at Risk for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection
A study testing Septra in people with Abscess, run by 59th Medical Wing at 1 site in United States.
Trial summary
Patients will be enrolled in a multi-center study to prospectively evaluate outcome after treatment for an uncomplicated skin abscess. All patients will receive incision and drainage and wound cultures. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Abscess
- What is being tested?
- Septra
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jun 2008
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- all patients age 18-55 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
- 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
- basic Military Trainees will also be excluded from participation
- 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
- 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
About this study
Official title: Prospective Randomized Controlled Trial of Antibiotic Treatment for Uncomplicated Skin Abscess in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection
Patients will be enrolled in a multi-center study to prospectively evaluate outcome after treatment for an uncomplicated skin abscess. All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1)no antibiotic or 2) bacterium double strength (DS) (800/160) two tablets per oral (PO) twice a day x 7 days. This is the dose recommended for treating skin and soft tissue infections. (Ellis et al. Current Opinion in Infectious Diseases. 18(6):496-501, December 2005) Patients will then return to the emergency room (ER) on days 3 and 7 for wound repacking and evaluation. The primary outcome is clinical cure of abscess at 7 days after incision and drainage and recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat. This serves as the pilot for the full placebo controlled randomized trial.
- Conditions
- Abscess
- Being tested
- Septra
- 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.
SeptraDrug
(800/125) PO BID X 7 days
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | No antibiotic |
| Septra DS | Active comparator | Septra DS (800/160) two pills PO BID x 7 days Receives: Drug: Septra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Improvement at 7 Days After Incision and Drainage
improving wound without evidence of fever, worsening cellulitis or induration
Measured: 7 days
Secondary outcomes (1)
Recurrence Rates
recurrence of abscess in previous or new location within 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startJun 2008
- Primary completionJun 2008
- Study completionJun 2008
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.
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- 59th Medical Wing
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Gillian Schmitz, 59th Medical Wing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829686
- Sponsor's protocol ID
- FWH20080055H-Pilot
- Status last verified
- May 2017
- First submitted
- 26 Jan 2009
- Last updated
- 9 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial of Antibiotic Treatment for Uncomplicated Skin Abscess in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection
- ClinicalTrials.gov ID
- NCT00829686
- Acronym / sponsor ID
- FWH20080055H-Pilot
- Conditions
- Abscess
- Keywords
- abscess, cellulitis, antibiotics, MRSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- 59th Medical WingUS federal agency
- Study start
- Jun 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 27 Jan 2009 (estimated)
- Results
- Posted 28 Jul 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 to prospectively evaluate outcome after treatment for an uncomplicated skin abscess. All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1)no antibiotic or 2) bacterium double strength (DS) (800/160) two tablets per oral (PO) twice a day x 7 days. This is the dose recommended for treating skin and soft tissue infections. (Ellis et al. Current Opinion in Infectious Diseases. 18(6):496-501, December 2005) Patients will then return to the emergency room (ER) on days 3 and 7 for wound repacking and evaluation. The primary outcome is clinical cure of abscess at 7 days after incision and drainage and recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat. This serves as the pilot for the full placebo controlled randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –No antibiotic |
| Septra DS | Active comparator | Drug: SeptraSeptra DS (800/160) two pills PO BID x 7 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all patients age 18-55 who present to the emergency department with a skin abscess that requires incision and drainage.
Key exclusion criteria (6 listed)
- patients with diabetes, HIV, cancer or other immunocompromised patients
- 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
- basic Military Trainees will also be excluded from participation
- 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
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 |
|---|---|---|
| Septra(800/125) PO BID X 7 days | Drug | Septra DS |
Primary outcome
Clinical Improvement at 7 Days After Incision and Drainage
Time frame: 7 days
improving wound without evidence of fever, worsening cellulitis or induration
1 secondary outcome
Recurrence Rates
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Septra in people with Abscess, 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 6 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 9 Jun 2017. 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 28 Jul 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?
Clinical Improvement at 7 Days After Incision and Drainage (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2017.