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...
Date First Received: December 1, 2005
Last Updated: January 16, 2007
Verified by: University Children's Hospital Basel, January 2007
Clinical Trial Phase: Phase 4 | Start Date: October 2005
Overall Status: Terminated
Estimated Enrollment: 194
Brief Summary
Official Title: “Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Dermatitis - an Open, Randomized, Controlled Trial”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Detailed Clinical Trial 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).
Intervention(s) in this Clinical Trial
- Drug: Penicillin versus cefuroxim per os
Outcome Measures for this Clinical Trial
Primary Measures
- Resolving signs and symptoms of perianal dermatitis
Secondary Measures
- microbiological cure (= negative culture for GABHS) at end of treatment
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 1 Year
Maximum Age for this Clinical Trial: 16 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University Children's Hospital Basel
Overall Clinical Trial Officials and Contacts
Ulrich Heininger, MD Principal Investigator University Children's Hospital Basel
Related Publications
References
Landolt M, Heininger U. [Prevalence of perianal streptococcal dermatitis in children and adolescents] Schweiz Rundsch Med Prax. 2005 Sep 21;94(38):1467-71. German.
Additional Information
Information obtained from ClinicalTrials.gov on December 03, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00261742
Study ID Number: 214/05
ClinicalTrials.gov Identifier: NCT00261742
Health Authority: Switzerland: Swissmedic
Clinical Trials Authorship and Review
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