Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Streptococcal Dermatitis
|ClinicalTrials.gov Identifier: NCT00261742|
Recruitment Status : Terminated
First Posted : December 5, 2005
Last Update Posted : January 17, 2007
|Condition or disease||Intervention/treatment||Phase|
|Streptococcal Infections||Drug: Penicillin versus cefuroxim per os||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||194 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Dermatitis - an Open, Randomized, Controlled Trial|
|Study Start Date :||October 2005|
|Estimated Study Completion Date :||December 2006|
- Resolving signs and symptoms of perianal dermatitis
- microbiological cure (= negative culture for GABHS) at end of treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261742
|University Children's Hospital|
|Basel, Switzerland, CH-4005|
|Principal Investigator:||Ulrich Heininger, MD||University Children's Hospital Basel|
|Study Director:||Urs B Schaad, MD||University Children's Hospital Basel|