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

January 16, 2007 updated by: University Children's Hospital Basel

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / 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).

Study Type

Interventional

Enrollment

194

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, CH-4005
        • University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Resolving signs and symptoms of perianal dermatitis

Secondary Outcome Measures

Outcome Measure
microbiological cure (= negative culture for GABHS) at end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

December 1, 2005

First Submitted That Met QC Criteria

December 1, 2005

First Posted (ESTIMATE)

December 5, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 17, 2007

Last Update Submitted That Met QC Criteria

January 16, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 214/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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