NCT00261742

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

January 17, 2007

Status Verified

January 1, 2007

First QC Date

December 1, 2005

Last Update Submit

January 16, 2007

Conditions

Streptococcal Infections

Keywords

perianaldermatitisstreptococcus pyogenes

Outcome Measures

Primary Outcomes (1)

  • Resolving signs and symptoms of perianal dermatitis

Secondary Outcomes (1)

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

Interventions

Penicillin versus cefuroxim per osDRUG

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital

Basel, CH-4005, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 16209362BACKGROUND

MeSH Terms

Conditions

Streptococcal InfectionsDermatitis

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ulrich Heininger, MD

    University Children's Hospital Basel

    PRINCIPAL INVESTIGATOR

  • Urs B Schaad, MD

    University Children's Hospital Basel

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 1, 2005

First Posted

December 5, 2005

Study Start

October 1, 2005

Study Completion

December 1, 2006

Last Updated

January 17, 2007

Record last verified: 2007-01

Locations

CH(1)