DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: University Children's Hospital Basel
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Streptococcal Infections

Intervention: Penicillin versus cefuroxim per os (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: University Children's Hospital Basel

Official(s) and/or principal investigator(s):
Ulrich Heininger, MD, Principal Investigator, Affiliation: University Children's Hospital Basel
Urs B Schaad, MD, Study Director, Affiliation: University Children's Hospital Basel

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.

Clinical Details

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

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

Primary outcome: Resolving signs and symptoms of perianal dermatitis

Secondary outcome: microbiological cure (= negative culture for GABHS) at end of 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).

Eligibility

Minimum age: 1 Year. Maximum age: 16 Years. Gender(s): Both.

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

Locations and Contacts

University Children's Hospital, Basel CH-4005, Switzerland
Additional Information

Related publications:

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

Starting date: October 2005
Last updated: January 16, 2007

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017