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

Sponsored by:	Baylor College of Medicine
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00691600

Purpose

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.

Condition	Intervention	Phase
Abscess	Drug: oral trimethoprim/sulfamethoxazole Drug: Placebo Other: Observational Unit Short Stay Other: Hospitalization	Phase III

Drug Information available for: Sulfamethoxazole Trimethoprim Trimethoprim-sulfamethoxazole combination

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	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.

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	472
Study Start Date:	December 2007
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
TMP/SMX vs Placebo: Placebo Comparator subjects with abscesses less than 5cm will be randomized to either study med or placebo	Drug: oral trimethoprim/sulfamethoxazole 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days Drug: Placebo Placebo caps or suspension every 12 hours for 10 days
Hospitalization vs. 23 HR OBS Unit Patients with abscesses 5-10cm will be randomized to either inpatient stay or 23 hour short stay in the observation unit.	Other: Observational Unit Short Stay Patients with abscesses greater that 5cm to 10cm randomized to Observational Short Stay unit for up to 23 hrs. Other: Hospitalization Patients with abscesses 5-10cm may be randomized to inpatient treatment

Eligibility

Ages Eligible for Study:	90 Days to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691600

Locations

United States, Texas
Texas Children's Hospital	Recruiting
Houston, Texas, United States, 77030
Contact: Brian Schultz, MD 832-824-5497 schultz@bcm.edu
Contact: Troy Bush, BS 832-824-2246 tbush@bcm.edu
Principal Investigator: Charles G Macias, MD, MPH
Sub-Investigator: Brian Schultz, MD

Sponsors and Collaborators

Baylor College of Medicine

More Information

Responsible Party:	Baylor College of Medicine ( Charles Macias, MD, MPH )
Study ID Numbers:	H-18758
Study First Received:	December 28, 2007
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00691600
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:

abscess
Abscesses in the pediatric emergency population

Study placed in the following topic categories:

Folic Acid
Trimethoprim
Sulfamethoxazole
Abscess

Suppuration
Emergencies
Trimethoprim-Sulfamethoxazole Combination
Inflammation

Additional relevant MeSH terms:

Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Infection
Renal Agents

Folic Acid Antagonists
Pharmacologic Actions
Antimalarials
Antiparasitic Agents
Pathologic Processes
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009