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

Streptococcal Infections Clinical Trial

Official title:

Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Dermatitis - an Open, Randomized, Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00261742
• Other study ID #: 214/05
• Status: Terminated
• Phase: Phase 4
• First received: December 1, 2005
• Last updated: January 16, 2007
• Start date: October 2005
• Est. completion date: December 2006

Study information

• Verified date: January 2007
• Source: University Children's Hospital Basel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 194
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 16 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Streptococcal Infections

Intervention

Drug:
• Penicillin versus cefuroxim per os

Locations

Country	Name	City	State
Switzerland	University Children's Hospital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital Basel

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Landolt M, Heininger U. [Prevalence of perianal streptococcal dermatitis in children and adolescents]. Praxis (Bern 1994). 2005 Sep 21;94(38):1467-71. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolving signs and symptoms of perianal dermatitis
Secondary	microbiological cure (= negative culture for GABHS) at end of treatment