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:
- Describe the molecular epidemiology of Clostridium Difficile infection in children in the Chicago area.
- Determine the clinical spectrum and risk factors for Clostridium Difficile infection secondary to particular endemic strains in children.
- 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
Study Sites (1)
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