Clostridium Difficile Virulence Mechanism Study (CDVM Study)

• Conditions: Clostridium Difficile; Clostridium Difficile Infection

• Registration Number: NCT03654872
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

This is an observational study to collect stool samples from patients with Clostridium difficile infection (CDI), aims to (1) to investigate the virulence mechanisms of C. difficile ribotype 002, by analysing its growth, cytotoxicity, and metabolite production in vitro and in vivo. The investigators also aim (2) to compare these virulence mechanisms with other common ribotypes in Asia, and (3) to correlate these with important clinical outcomes. The results of this study will have a major significance to the medical and scientific community. The results of this study will have a major significance to the medical and scientific community. The mechanistic data will point to important molecular pathways that can be targeted for novel therapies; whereas the phenotypic data will inform the investigators of its virulence and therefore will be useful for disease surveillance and public health interventions. The identified toxin(s) and metabolite(s) may be useful as prognostic biomarkers to stratify patients with different outcomes, as patients with a worse outcome may require more aggressive therapy. Given the prevalence and severity of this ribotype, the results will be useful for gastroenterologists, microbiologists, infectious diseases physicians and public health specialists in the Asia Pacific region.

Study Timeline

• Study Start: 2018-06-30
• Status Verified: 2018-08
• Study First Submitted: 2018-08-19
• Study First Submitted QC: 2018-08-30
• Last Update Submitted: 2018-08-30
• Study First Posted: 2018-08-31
• Last Update Posted: 2018-08-31
• Primary Completion: 2019-05-30
• Study Completion: 2019-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 227

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Isolate Clostridium difficile from patients' stool for ribotyping to identify which ribotype was the Clostridium difficile from the patient.	1 year	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.

Trial Locations

Locations (1)

Prince of Wales Hospital, The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong