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TerminatedNCT00261742Updated Jan 17, 2007

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

A Phase 4 interventional study of Penicillin versus cefuroxim per os in Streptococcal Infections, sponsored by University Children's Hospital Basel. Terminated at 1 site in Switzerland. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2007-01-17.

Sponsored by University Children's Hospital Basel · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
194
Allocation
Randomized
Ages
1 Year to 16 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Streptococcal Infections

Keywords

  • perianal
  • dermatitis
  • streptococcus pyogenes
03

In context

Streptococcal Infections

155 studies on the registry are indexed under Streptococcal Infections; 15 are open to participants now.

This study's enrollment of 194 is below the median of 250 across 105 interventional studies indexed under Streptococcal Infections.

Browse Streptococcal Infections studies →

Lead sponsor

University Children's Hospital Basel is the lead sponsor of 27 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • informed consent
  • age 1-16 years
  • typical clinical symptoms for perianal dermatitis
  • positive perianal culture for GABHS

Exclusion criteria

Exclusion Criteria:

  • antibiotic treatment in previous 14 days
  • immunodeficiency
  • penicillin allergy
  • cephalosporin allergy
  • further bacterial infections
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
194 participants

Interventions

  • DrugPenicillin versus cefuroxim per os
06

What researchers measure

Primary outcomes

  1. Resolving signs and symptoms of perianal dermatitis

Secondary outcomes

  1. microbiological cure (= negative culture for GABHS) at end of treatment

07

Study locations

1 site
  • University Children's Hospital
    Basel, CH-4005, Switzerland
08

References and documents

Publications

  • Landolt M, Heininger U. [Prevalence of perianal streptococcal dermatitis in children and adolescents]. Praxis (Bern 1994). 2005 Sep 21;94(38):1467-71. doi: 10.1024/0369-8394.94.38.1467. German. PubMed 16209362 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00261742
Lead sponsor
University Children's Hospital Basel
First posted
Dec 5, 2005
Start date
Oct 2005
Completion
Dec 2006
Last update
Jan 17, 2007

Study contacts

Ulrich Heininger, MD
principal investigator · University Children's Hospital Basel
Urs B Schaad, MD
study director · University Children's Hospital Basel
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2007. You cannot join it, but the record below documents what was studied.

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