Molecular Epidemiology of Clostridium Difficile Infections in Children

Completed

• Conditions: Clostridium Difficile Infections

• Registration Number: NCT01957761
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-19
• Status Verified: 2013-10
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2016-01-26
• Results First Submitted QC: 2016-01-26
• Last Update Submitted: 2016-01-26
• Results First Posted: 2016-02-23
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Clostridium Difficile infection

Exclusion Criteria

• Age < 1 year
• Age > 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clostridium Difficile Infections Strain Type Based on Restriction Endonuclease Analysis	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.

Trial Locations

Locations (1)

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States