Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Streptococcal Dermatitis
Information source: University Children's Hospital Basel
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Streptococcal Infections
Intervention: Penicillin versus cefuroxim per os (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: University Children's Hospital Basel Official(s) and/or principal investigator(s):
Ulrich Heininger, MD, Principal Investigator, Affiliation: University Children's Hospital Basel
Urs B Schaad, MD, Study Director, Affiliation: University Children's Hospital Basel
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.
Clinical Details
Official title: Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Dermatitis - an Open, Randomized, Controlled Trial
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Resolving signs and symptoms of perianal dermatitis
Secondary outcome: microbiological cure (= negative culture for GABHS) at end of treatment
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).
Eligibility
Minimum age: 1 Year.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University Children's Hospital, Basel CH-4005, Switzerland
Additional Information
Related publications: 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.
Starting date: October 2005
Ending date: December 2006
Last updated: January 16, 2007
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