Text Size

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

This study has been terminated.
Sponsor:
Information provided by:
University Children's Hospital Basel
ClinicalTrials.gov Identifier:
NCT00261742
First received: December 1, 2005
Last updated: January 16, 2007
Last verified: January 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Streptococcal Infections
 Drug: Penicillin versus cefuroxim per os
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Dermatitis - an Open, Randomized, Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Children's Hospital Basel:

Primary Outcome Measures:
  • Resolving signs and symptoms of perianal dermatitis

Secondary Outcome Measures:
  • microbiological cure (= negative culture for GABHS) at end of treatment

Estimated Enrollment: 194
Study Start Date: October 2005
Estimated Study Completion Date: December 2006
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

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261742

Locations
Switzerland
University Children's Hospital
Basel, Switzerland, CH-4005
Sponsors and Collaborators
University Children's Hospital Basel
Investigators
Principal Investigator: Ulrich Heininger, MD University Children's Hospital Basel
Study Director: Urs B Schaad, MD University Children's Hospital Basel
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00261742     History of Changes
Other Study ID Numbers: 214/05
Study First Received: December 1, 2005
Last Updated: January 16, 2007
Health Authority: Switzerland: Swissmedic

Keywords provided by University Children's Hospital Basel:
perianal
dermatitis
streptococcus pyogenes

Additional relevant MeSH terms:
Dermatitis
Streptococcal Infections
Skin Diseases
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 22, 2013