Management of Skin and Soft Tissue Abscesses in Pediatric Patients After Incision and Drainage - Tabular View

Tracking Information
First Received Date ^ICMJE	December 28, 2007
Last Updated Date	June 3, 2008
Start Date ^ICMJE	December 2007
Estimated Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 3, 2008)	Proportion of patients having abscess resolution to those that do not for each of the treatment modalities employed. For the < 5 cm arm, compare the proportions of patients with successful outcomes between the placebo and TMP/SMX groups. [ Time Frame: 3yrs ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00691600 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 3, 2008)	The 5 - 10 cm arm, will compare the proportions of patients with successful outcomes between the 23-hour observation and hospitalization groups. [ Time Frame: 3yrs ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Management of Skin and Soft Tissue Abscesses in Pediatric Patients After Incision and Drainage
Official Title ^ICMJE	Phase 3 Study Comparing Bactrim to Placebo in the Management of Abscesses < 5cm and 23 hr Observation Unit to Inpatient Treatment in the Management of Abscesses 5-10cm in the Pediatric Population.
Brief Summary	The purpose of this study is to compare successful rates of cure of abscesses less than 5 cm with antibiotic versus non-antibiotic treatment after incision and drainage. We will also compare successful rates of cure and time to healing with IV antibiotics and 23-hour observation unit stay versus hospitalization with IV antibiotics for abscesses greater than 5 cm but less than 10 cm in pediatric patients.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Condition ^ICMJE	Abscess
Intervention ^ICMJE	Drug: oral trimethoprim/sulfamethoxazole Drug: Placebo Other: Observational Unit Short Stay Other: Hospitalization
Study Arms / Comparison Groups	Placebo Comparator: subjects with abscesses less than 5cm will be randomized to either study med or placebo Other: Patients with abscesses 5-10cm will be randomized to either inpatient stay or 23 hour short stay in the observation unit.
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	472
Completion Date
Estimated Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Fluctuant abscess on trunk, scalp, extremities and axilla. Exclusion Criteria: Multiple abscesses Abscesses greater than 10 cm Abscesses located on the hands, face, and perineum Bite wounds Immunocompromised patients (including diabetes, sickle cell, chronic steroid therapy, etc.) Previously failed 48 hours or greater therapy on any antibiotic regimen Abscess less than 5 cm AND patient has (for exclusion criteria 7 - 10): Drug allergy to TMP/SMX Fever greater than or equal to 102.2 degrees F in last 24 hours Systemic symptoms on presentation - i.e., nausea, vomiting, diaphoresis, etc. \ Signs/symptoms of another infection or illness - i.e., influenza, croup, etc. Abscess 5 - 10 cm AND patient has (for exclusion criterion 11): \ Drug allergy to both Clindamycin AND Vancomycin
Gender	Both
Ages	90 Days to 18 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00691600
Responsible Party	Charles Macias, MD, MPH, Baylor College of Medicine
Study ID Numbers ^ICMJE	H-18758
Study Sponsor ^ICMJE	Baylor College of Medicine
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Baylor College of Medicine
Verification Date	June 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP