AbscessPhase 3NCT00691600
Management of Skin and Soft Tissue Abscesses in Pediatric Patients After Incision and Drainage
A Phase 3 study testing oral trimethoprim/sulfamethoxazole in people with Abscess, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of the study is to compare rates of cure of abscesses with and without antibiotic treatment after incision and drainage. The purpose of this study is to compare successful rates of cure of abscesses less than 5 cm with antibiotic (oral TMP/SMX) versus non-antibiotic treatment after incision and drainage. Read more about this study
- Who is it for?
- Ages 90 days to 18 years
- Conditions the study is for
- Abscess
- What is being tested?
- oral trimethoprim/sulfamethoxazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Apr 2010
- Phase
- Phase 3
- 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 90 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1.) Abscess < 5 cm (< 5 cm of induration and fluctuance) requiring incision and drainage 2.) Age > 90 days and < 18 years 3.) Abscess on the trunk, scalp, extremities, or axillae
Who cannot join
- Multiple abscesses
- Abscess located on the hands, face, or perineum
- Abscess as a result of a bite wound
- Immunocompromised patient - i.e., diabetes, sickle cell, chronic steroid therapy (> 10 days), etc.
- Previously failed 48 hours or greater therapy on any antibiotic regimen 6.) Drug allergy to TMP/SMX
- 7.) Fever > or = 102.2 degrees Fahrenheit in the previous 24 hours 8.) Systemic symptoms on presentation - i.e., nausea , vomiting, persistent tachycardia, hypotension, diaphoresis, etc.
- 9.) Signs /symptoms of another infection or illness - i.e., influenza, croup, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study Comparing Bactrim to Placebo in the Management of Abscesses < 5cm in the Pediatric Population.
The purpose of the study is to compare rates of cure of abscesses with and without antibiotic treatment after incision and drainage. The purpose of this study is to compare successful rates of cure of abscesses less than 5 cm with antibiotic (oral TMP/SMX) versus non-antibiotic treatment after incision and drainage.
Read the detailed description
This study is a randomized controlled trial of antibiotic treatment versus placebo after incision and drainage of skin and soft tissue abscesses less than 5 cm in pediatric patients. Eligible patients whose parents/guardians consented them to enrollment were randomized to receive one of two interventions: oral trimethoprim/sulfamethoxazole (TMP/SMX) or placebo after incision and drainage. Every attempt was made to make the placebo capsules and suspensions appear in all aspects like the true drug (was done by the investigational pharmacy department at our institution). Equal numbers of subjects were randomized at the outset to both study groups. Randomization, also done by our investigational pharmacy department, was done in blocks of 20. Patients were followed up in our emergency center at 24 to 48 hours to have any packing removed and to have their clinical/wound status assessed. They were not charged for this visit, and their valet parking was validated. If an individual patient, or an individual patient's wound, was felt to be not improving adequately, that patient was started on formal antibiotic therapy at the treating attending physician's discretion.
Primary outcome:
- Abscess resolution by parental report 7-10 days after incision and drainage
Secondary outcomes:
- Admission to the hospital because of worsening infection
- Receipt of antibiotics (placebo arm) or change in antibiotics (antibiotic arm)
- Conditions
- Abscess
- Being tested
- oral trimethoprim/sulfamethoxazole, Placebo
- Keywords
- abscess, Abscesses in the pediatric emergency population
- Medical subject headings
- Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral trimethoprim/sulfamethoxazoleDrug
Also called TMP/SMX
80 mg caps or 8 mg/ml suspension every 12 hours for 10 days
PlaceboDrug
Also called Placebo caps
Placebo caps or suspension every 12 hours for 10 days
| Study group | Role | What they receive |
|---|---|---|
| oral trimethoprim/sulfamethoxazole | Active comparator | subjects with abscesses less than 5cm will be randomized to either study med or placebo Receives: Drug: oral trimethoprim/sulfamethoxazole |
| placebo | Placebo comparator | Placebo after incision and drainage of abscess less than 5 cm. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Abscess Resolution
Outcomes will be measured by resolution of size, tenderness, and induration with erythema by parental report 7 - 10 days after initial visit to the Emergency Center
Measured: 10 days
Secondary outcomes (2)
Number of Participants Requiring Admission for Failure of Abscess Resolution
Percentage of patients requiring admission to Texas Children's or another hospital within 10 days of incision and drainage
Measured: 10 days
Number of Participants Requiring New or Modified Antibiotics for Failure of Abscess to Resolve
For the antibiotic arm, we determined if the child was prescribed a different antibiotic.
For the placebo arm, we determined if the child received a prescription for an antibiotic at a subsequent visit (e.g., in the emergency department, by their pediatrician, etc) within 10 days of incision and drainage
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startDec 2007
- Primary completionApr 2010
- Study completionApr 2010
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.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Cruz, Baylor College of Medicine
- Investigators
- Andrea Cruz, MD, MPH, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691600
- Sponsor's protocol ID
- H-18758
- Status last verified
- Jun 2020
- First submitted
- 28 Dec 2007
- Last updated
- 1 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study Comparing Bactrim to Placebo in the Management of Abscesses < 5cm in the Pediatric Population.
- ClinicalTrials.gov ID
- NCT00691600
- Acronym / sponsor ID
- H-18758
- Conditions
- Abscess
- Keywords
- abscess, Abscesses in the pediatric emergency population
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Posted 23 Jun 2020
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 the study is to compare rates of cure of abscesses with and without antibiotic treatment after incision and drainage. The purpose of this study is to compare successful rates of cure of abscesses less than 5 cm with antibiotic (oral TMP/SMX) versus non-antibiotic treatment after incision and drainage.
Detailed description
This study is a randomized controlled trial of antibiotic treatment versus placebo after incision and drainage of skin and soft tissue abscesses less than 5 cm in pediatric patients. Eligible patients whose parents/guardians consented them to enrollment were randomized to receive one of two interventions: oral trimethoprim/sulfamethoxazole (TMP/SMX) or placebo after incision and drainage. Every attempt was made to make the placebo capsules and suspensions appear in all aspects like the true drug (was done by the investigational pharmacy department at our institution). Equal numbers of subjects were randomized at the outset to both study groups. Randomization, also done by our investigational pharmacy department, was done in blocks of 20. Patients were followed up in our emergency center at 24 to 48 hours to have any packing removed and to have their clinical/wound status assessed. They were not charged for this visit, and their valet parking was validated. If an individual patient, or an individual patient's wound, was felt to be not improving adequately, that patient was started on formal antibiotic therapy at the treating attending physician's discretion.
Primary outcome:
- Abscess resolution by parental report 7-10 days after incision and drainage
Secondary outcomes:
- Admission to the hospital because of worsening infection
- Receipt of antibiotics (placebo arm) or change in antibiotics (antibiotic arm)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral trimethoprim/sulfamethoxazole | Active comparator | Drug: oral trimethoprim/sulfamethoxazolesubjects with abscesses less than 5cm will be randomized to either study med or placebo |
| placebo | Placebo comparator | Drug: PlaceboPlacebo after incision and drainage of abscess less than 5 cm. |
Who may qualify
- Ages
- 90 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1.) Abscess < 5 cm (< 5 cm of induration and fluctuance) requiring incision and drainage 2.) Age > 90 days and < 18 years 3.) Abscess on the trunk, scalp, extremities, or axillae
Key exclusion criteria (7 listed)
- Multiple abscesses
- Abscess located on the hands, face, or perineum
- Abscess as a result of a bite wound
- Immunocompromised patient - i.e., diabetes, sickle cell, chronic steroid therapy (> 10 days), etc.
- Previously failed 48 hours or greater therapy on any antibiotic regimen 6.) Drug allergy to TMP/SMX
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 |
|---|---|---|
| oral trimethoprim/sulfamethoxazoleAlso: TMP/SMX80 mg caps or 8 mg/ml suspension every 12 hours for 10 days | Drug | oral trimethoprim/sulfamethoxazole |
| PlaceboAlso: Placebo capsPlacebo caps or suspension every 12 hours for 10 days | Drug | placebo |
Primary outcome
Number of Participants With Abscess Resolution
Time frame: 10 days
Outcomes will be measured by resolution of size, tenderness, and induration with erythema by parental report 7 - 10 days after initial visit to the Emergency Center
2 secondary outcomes
Number of Participants Requiring Admission for Failure of Abscess Resolution
Time frame: 10 days
Number of Participants Requiring New or Modified Antibiotics for Failure of Abscess to Resolve
Time frame: 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Andrea Cruz, MD, MPH principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oral trimethoprim/sulfamethoxazole in people with Abscess, run by Baylor College of Medicine 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 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: finished, as of the sponsor's last update on 1 Jul 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2020). 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?
Number of Participants With Abscess Resolution (time frame: 10 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 1 Jul 2020.