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Clinical Trials/NCT01957761
NCT01957761CompletedNot Applicable

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

Ann & Robert H Lurie Children's Hospital of Chicago1 site in 1 country132 target enrollmentStarted: October 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
132
Locations
1
Primary Endpoint
Clostridium Difficile Infections Strain Type Based on Restriction Endonuclease Analysis

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
1 Year to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Clostridium Difficile infection

Exclusion Criteria

  • Age < 1 year
  • Age > 18 years

Outcomes

Primary Outcomes

Clostridium Difficile Infections Strain Type Based on Restriction Endonuclease Analysis

Time Frame: On day 1 of diagnosis of Clostridium difficile infection

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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