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

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ClinicalTrials.gov Identifier: NCT00261742
Recruitment Status : Terminated
First Posted : December 5, 2005
Last Update Posted : January 17, 2007
Sponsor:
Information provided by:
University Children's Hospital Basel

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.

Condition or disease Intervention/treatment Phase
Streptococcal Infections Drug: Penicillin versus cefuroxim per os Phase 4

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  (Clinical Trial)
Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Dermatitis - an Open, Randomized, Controlled Trial
Study Start Date : October 2005
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Resolving signs and symptoms of perianal dermatitis

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


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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00261742     History of Changes
Other Study ID Numbers: 214/05
First Posted: December 5, 2005    Key Record Dates
Last Update Posted: January 17, 2007
Last Verified: January 2007

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
Penicillins
Cefuroxime
Cefuroxime axetil
Anti-Bacterial Agents
Anti-Infective Agents