Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Streptococcal Dermatitis
Primary Purpose
Streptococcal Infections
Status
Terminated
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Penicillin versus cefuroxim per os
Sponsored by
About this trial
This is an interventional treatment trial for Streptococcal Infections focused on measuring perianal, dermatitis, streptococcus pyogenes
Eligibility 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
Sites / Locations
- University Children's Hospital
Outcomes
Primary Outcome Measures
Resolving signs and symptoms of perianal dermatitis
Secondary Outcome Measures
microbiological cure (= negative culture for GABHS) at end of treatment
Full Information
NCT ID
NCT00261742
First Posted
December 1, 2005
Last Updated
January 16, 2007
Sponsor
University Children's Hospital Basel
1. Study Identification
Unique Protocol Identification Number
NCT00261742
Brief Title
Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Streptococcal Dermatitis
Official Title
Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Dermatitis - an Open, Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Terminated
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Children's Hospital Basel
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Streptococcal Infections
Keywords
perianal, dermatitis, streptococcus pyogenes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
194 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Penicillin versus cefuroxim per os
Primary Outcome Measure Information:
Title
Resolving signs and symptoms of perianal dermatitis
Secondary Outcome Measure Information:
Title
microbiological cure (= negative culture for GABHS) at end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Heininger, MD
Organizational Affiliation
University Children's Hospital Basel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Urs B Schaad, MD
Organizational Affiliation
University Children's Hospital Basel
Official's Role
Study Director
Facility Information:
Facility Name
University Children's Hospital
City
Basel
ZIP/Postal Code
CH-4005
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
16209362
Citation
Landolt M, Heininger U. [Prevalence of perianal streptococcal dermatitis in children and adolescents]. Praxis (Bern 1994). 2005 Sep 21;94(38):1467-71. doi: 10.1024/0369-8394.94.38.1467. German.
Results Reference
background
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Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Streptococcal Dermatitis
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