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

NCT ID: NCT00261742

Last Updated: 2007-01-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2006-12-31

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).

Conditions

Streptococcal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Penicillin versus cefuroxim per os

Intervention Type: DRUG

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Children's Hospital Basel

OTHER

Sponsor Role: lead

Principal Investigators

Ulrich Heininger, MD

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital Basel

Urs B Schaad, MD

Role: STUDY_DIRECTOR

University Children's Hospital Basel

Locations

University Children's Hospital

Basel, , Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 16209362 (View on PubMed)

Other Identifiers

214/05

Identifier Type: -

Identifier Source: org_study_id