The Burden and Genetic Variability of Extended-Spectrum ß-Lactamase (ESBL) - Producing Pathogens in Swiss Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University Hospital, Geneva.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00894036
First received: May 4, 2009
Last updated: September 24, 2009
Last verified: May 2009
  Purpose

Objectives:

The aim of the study is to determine the molecular epidemiology and genetic variability of ESBL-producing enterobacteriaceae (E-ESBL) among children in Switzerland and to estimate the associated clinical burden of disease.

The investigators' hypotheses are:

  1. The genetic variability (and especially the distribution of strains harbouring the CTX-M genes) among children is similar to that observed in adults;
  2. The overall burden of disease is still low in Switzerland compared to neighbouring countries. However, treatment of severe E-ESBL infections is challenging;
  3. The recommended oral treatment procedure with 3rd generation cephalosporins for febrile urinary tract infection may contribute to increased prevalence of E-ESBL in the long term.

The study is scheduled to start July 1st, 2008, and end June 30th, 2010.


Condition
Enterobacteriaceae Infections

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Epidemiology of Extended-spectrum ß-lactamase (ESBL)-Producing Enteric Gram-negative Bacilli in Swiss Children

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Burden of ESBL-colonization and disease of hospitalized Swiss children [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Genetic variability (and especially the distribution of strains harbouring the CTX-M genes) among Swiss children [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All children hospitalized in a pediatric hospital or a pediatric unit in Switzerland

Criteria

Inclusion Criteria:

  • children who are found being colonized or infected by an ESBL-producing pathogen

Exclusion Criteria:

  • children without ESBL-producing pathogens
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00894036

Contacts
Contact: Walter Zingg, MD +41223723364 walter.zingg@hcuge.ch
Contact: Christoph Aebi, Prof +41316322111 christoph.aebi@insel.ch

Locations
Switzerland
University of Geneva Hospitals Recruiting
Geneva, Switzerland, 1211
Contact: Walter Zingg, MD    +41223723364    walter.zingg@hcuge.ch   
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Study Chair: Christoph Aebi, Prof University Hospital of Berne
  More Information

Publications:

Responsible Party: Walter Zingg/MD, University of Geneva Hospitals
ClinicalTrials.gov Identifier: NCT00894036     History of Changes
Other Study ID Numbers: MatPed 08-002R
Study First Received: May 4, 2009
Last Updated: September 24, 2009
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by University Hospital, Geneva:
esbl children Switzerland
Colonization
ESBL-producing gram-negative bacilli
Infection

Additional relevant MeSH terms:
Infection
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 18, 2014