Clostridium Difficile Virulence Mechanism Study (CDVM Study)

NCT03654872 | Unknown

• 1 other identifier: CDVMProtocol
• Study Type: observational
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an observational study to collect stool samples from patients with Clostridium difficile infection (CDI) to investigate the virulence mechanisms of C. difficile ribotypes in Hong Kong, mainly ribotype 002. No intervention is involved.

Conditions

Clostridium Difficile Infection; Clostridium Difficile

Keywords

ribotypes; Hong Kong; virulence mechanism

Outcome Measures

Primary Outcomes (1)

• Isolate Clostridium difficile from patients' stool for ribotyping to identify which ribotype was the Clostridium difficile from the patient.

  Clostridium difficile will be isolated from stool sample of the patients and will be used for ribotyping. Ribotyping will be done to the Clostridium difficile strain isolated to classify them into different ribotypes. This is to measure the number of patients with a particular ribotype. Virulence mechanism will also be evaluated through experiments with isolated bacteria on growth curve, toxin production, sporulation, germination and adhesion.

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects will be identified and recruited under the suitable patients pool in the apply site. If the subjects are confirmed to have diarrheal symptoms and positivie stool result of Clostridium difficile, the subjects will be recruited in the wards and will only be recruited if they sign the informed consent.

You may qualify if:

• Patients with a confirmed diagnosis of CDI, as documented by diarrheal symptoms and positive stool test result for C. difficile toxin or toxigenic C. difficile, or colonoscopic findings of pseudomembranous colitis (PMC).
• Patients aged over or equal to 18 years old.
• Patients able and willing to provide informed consent.

You may not qualify if:

• Patients with concomitant infection by other microbes such as Salmonella, Campylobacter, Vibrio, Shigella, and Escherichia coli.
• Patients under 18 years old.
• Patients who cannot give consent.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA from stool maybe extracted for analysis

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr. Sunny Wong

  Institute of Digestive Disease, Department of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Sunny Wong

CONTACT

35051459; wonghei@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Assistant Professor

Study Record Dates

• First Submitted: August 19, 2018
• First Posted: August 31, 2018
• Study Start: June 30, 2018
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

HK (1)