Molecular Epidemiology of Clostridium Difficile Infections in Children

NCT01957761 | Completed Results

• 1 other identifier: Merck MISP 50366
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives:

1. 1.Describe the molecular epidemiology of Clostridium Difficile infection in children in the Chicago area.
2. 2.Determine the clinical spectrum and risk factors for Clostridium Difficile infection secondary to particular endemic strains in children.
3. 3.Define the risk factors for recurrent and community-associated Clostridium Difficile infection in children.

Conditions

Clostridium Difficile Infections

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Clostridium difficile infection

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children with Clostridium Difficile infection

You may qualify if:

• Clostridium Difficile infection

You may not qualify if:

• Age \< 1 year
• Age \> 18 years

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Larry Kociolek, MD, MSCI
• Organization: Ann & Robert H. Lurie Children's Hospital of Chicago

lkociolek@luriechildrens.org

312-227-4080

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: October 8, 2013
• Study Start: October 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 23, 2016
• Results First Posted: February 23, 2016

Record last verified: 2013-10

Locations

US (1)