COMBACTE-CDI Understanding the Burden of C. Difficile Infection

NCT03503474 | Completed Results

• 1 other identifier: IRAS244784
• Study Type: observational
• Target: 3,240
• Locations: 1 country
• Sites: 1

Brief Summary

Clostridium difficile infection (CDI) is the most common cause of antibiotic associated diarrhoea in the western world. The infection causes significant diarrhoea, which in some cases can be serious and lead to secondary complications and even death. The infection is particularly an issue in elderly, frail patient, who are often already burdened with several other medical issues. Recent work has demonstrated that numerous cases are missed, either due to inadequate diagnostic tests or lack of clinical suspicion. The public-private partnership in COMBACTE-CDI will quantify the burden of CDI via a large, complex, multi-centre, multi-country study, and describe current management practices. An increased understanding of the CDI burden across Europe and better understanding of transmission of the organism will provide a basis for the further development of public health interventions and practices. Based on a previous successful study model (EUCLID), hospitals/laboratories of interest which carry out diagnostic testing of samples from both in-patients and community patients (including Long-Term Care Facilities patients) will be approached for inclusion in the study. Samples sent to the sites on the selected study date (regardless of test requested) will be tested at a central laboratory for CDI to look for missed cases of CDI. A follow up case/control study will collect data on outcomes and risk factors. Data will be used to construct transmission models and cost effective-ness models. Ultimately, a best practice model for CDI management will be developed.

Conditions

Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (1)

• The Number of Cases of CDI

  This outcome measure is to indicate the number of participants with a sample that returned a positive test result (=CDI cases) at the coordinating laboratory from the overall total number of participants. The number of CDI cases and negative controls are the number of participants with a sample that returned a positive or negative test result, respectively. Therefore the "CDI negative controls" arm did not return a positive test result. The proportion of participants that returned a positive test result compared to the total of participants (=number of participants in the "CDI cases" arm divided by the number of total participants in both arms) can be inferred from this outcome measure.

  Samples were received between July and December 2018 (at time of diarrheal episode) and test performed during that timeframe to identify the number of CDI cases (positive test result) and the number of CDI negative controls (negative test result).

Study Arms (2)

CDI cases

Other: No intervention

CDI negative controls

Other: No intervention

Interventions

No intervention OTHER

There is no intervention, this is observational only

CDI cases; CDI negative controls

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Anyone who has a diarrhoeal faecal sample submitted to the laboratories in the study for testing on the day of interest, regardless of test requested

You may qualify if:

• Anyone who has a diarrhoeal faecal sample submitted to the laboratories in the study for testing on the day of interest, regardless of test requested

You may not qualify if:

• Any repeat samples

Sponsors & Collaborators

• University of Leeds: lead
• Innovative Medicines Initiative: collaborator
• UMC Utrecht: collaborator
• Leiden University Medical Center: collaborator
• National laboratory for Health, Environment and Food, Slovenia: collaborator
• Universitätsklinikum Köln: collaborator
• Universiteit Antwerpen: collaborator
• National Institute for Infectious Diseases 'Lazzaro Sapllanzani', Italy: collaborator
• Universität Tübingen: collaborator
• Pfizer: collaborator
• GlaxoSmithKline: collaborator
• BioMérieux: collaborator
• AstraZeneca: collaborator
• Sanofi Pasteur, a Sanofi Company: collaborator
• Da Volterra: collaborator

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS1 3EX, United Kingdom

Location

Related Publications (1)

• Rupnik M, Viprey V, Janezic S, Tkalec V, Davis G, Sente B, Devos N, Muller BH, Santiago-Allexant E, Cleuziat P, Wilcox M, Davies K; COMBACTE-CDI consortium. Distribution of Clostridioides difficile ribotypes and sequence types across humans, animals and food in 13 European countries. Emerg Microbes Infect. 2024 Dec;13(1):2427804. doi: 10.1080/22221751.2024.2427804. Epub 2024 Nov 27.

  PMID: 39535868 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

residual diagnostic faecal samples

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Professor Mark Wilcox
• Organization: University of Leeds

mark.wilcox@nhs.net

+441133926818

Study Officials

• Mark Wilcox, MD

  University of Leeds

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Brotherton Chair of Microbiology

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 19, 2018
• Study Start: June 11, 2018
• Primary Completion: December 31, 2018
• Study Completion: September 30, 2019
• Last Updated: February 9, 2022
• Results First Posted: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)