Molecular Epidemiology of Clostridium Difficile Infections in Children

Clostridium Difficile Infections Clinical Trial

Official title:

Molecular Epidemiologic Survey and Risk Factor Assessment of Clostridium Difficile Infections in Children: A Focus on Recurrent and Community-associated Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957761
• Other study ID #: Merck MISP 50366
• Status: Completed
• Phase: N/A
• First received: November 19, 2012
• Last updated: January 26, 2016
• Start date: October 2012
• Est. completion date: June 2014

Study information

• Verified date: October 2013
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Objectives:

1. Describe the molecular epidemiology of Clostridium Difficile infection in children in the Chicago area.

2. Determine the clinical spectrum and risk factors for Clostridium Difficile infection secondary to particular endemic strains in children.

3. Define the risk factors for recurrent and community-associated Clostridium Difficile infection in children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• Clostridium Difficile infection

Exclusion Criteria:

• Age < 1 year

• Age > 18 years

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Clostridium Difficile Infections
• Communicable Diseases
• Infection

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clostridium Difficile Infections Strain Type Based on Restriction Endonuclease Analysis	Stool samples taken from patients with Clostridium Difficile Infections infection at the time of diagnosis will be assessed by restriction endonuclease analysis to determine strain type. In order to study the relationship between strain type and outcome of their infection (e.g, treatment failure, recurrence, complication of illness), patients will be followed throughout their illness and for 8 weeks after developing their infection.	On day 1 of diagnosis of Clostridium difficile infection	No