Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Streptococcal Dermatitis

Phase 4

Terminated

• Conditions: Streptococcal Infections

• Registration Number: NCT00261742
• Lead Sponsor: University Children's Hospital Basel

Brief Summary

The goal of the study is to investigate, which of two antibiotic treatments - oral penicillin for 10 days or oral cefuroxim for 7 days - is more successful for patients (1-16 years of age) with perianal dermatitis caused by group A beta-hemolytic streptococci.

Detailed Description

The goal of the study is to investigate, which of two antibiotic treatments - oral penicillin for 10 days or oral cefuroxim for 7 days - is more successful for patients (1-16 years of age) with perianal dermatitis caused by group A beta-hemolytic streptococci (GABHS). Diagnosis is based on positive perianal culture for GABHS. Informed consent will be obtained.

The study will be performed in the region of Basel, Switzerland, in private practices of pediatricians, general practitioners, and selected pediatric dermatologists as well as in the out-patient departments of the University Children's Hospital Basel and the department for dermatology of the University of Basel.

Patients (or their parents) will fill in a daily diary on signs and symptoms of disease; furthermore, clinical investigations (inspection of the site of infection) will be performed on enrollment (Day 1), Day 3, and at the end of treatment (Day 10).

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-12-01
• Study First Submitted QC: 2005-12-01
• Study First Posted: 2005-12-05
• Study Completion: 2006-12
• Status Verified: 2007-01
• Last Update Submitted: 2007-01-16
• Last Update Posted: 2007-01-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

• informed consent
• age 1-16 years
• typical clinical symptoms for perianal dermatitis
• positive perianal culture for GABHS

Exclusion Criteria

• antibiotic treatment in previous 14 days
• immunodeficiency
• penicillin allergy
• cephalosporin allergy
• further bacterial infections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Resolving signs and symptoms of perianal dermatitis

Secondary Outcome Measures

Name	Time	Method
microbiological cure (= negative culture for GABHS) at end of treatment

Trial Locations

Locations (1)

University Children's Hospital; 🇨🇭 Basel, Switzerland