Clinical trial NCT03654872: Clostridium Difficile Virulence Mechanism Study (CDVM Study)
Official title: Clostridium Difficile Virulence Mechanism Study by Collecting Stool Samples From Clostridium Difficile Infection Patients (CDVM Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Clostridium Difficile Infection
Clostridium Difficile
Keywords: ribotypes
Hong Kong
virulence mechanism
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Isolate Clostridium difficile from patients' stool for ribotyping to identify which ribotype was the Clostridium difficile from the patient.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital, The Chinese University of Hong Kong
Study officials:
affiliation: Institute of Digestive Disease, Department of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong
name: Dr. Sunny Wong
role: PRINCIPAL_INVESTIGATOR
References: