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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01957761
Other study ID # Merck MISP 50366
Secondary ID
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


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
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