Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Streptococcal Dermatitis - Full Text View

Sponsor:	University Children's Hospital Basel
Information provided by:	University Children's Hospital Basel
ClinicalTrials.gov Identifier:	NCT00261742

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Dermatitis - an Open, Randomized, Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Streptococcal Infections

Drug Information available for: Penicillins

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:

Landolt M, Heininger U. [Prevalence of perianal streptococcal dermatitis in children and adolescents] Schweiz Rundsch Med Prax. 2005 Sep 21;94(38):1467-71. German.

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

Keywords provided by University Children's Hospital Basel:

perianal
dermatitis
streptococcus pyogenes

Additional relevant MeSH terms:

Bacterial Infections
Gram-Positive Bacterial Infections
Skin Diseases

Streptococcal Infections
Infection
Dermatitis

ClinicalTrials.gov processed this record on February 08, 2010