COMBACTE-CDI Understanding the Burden of C. Difficile Infection

Clostridium Difficile Infection Clinical Trial

— COMBACTE-CDI  

Official title:

Combatting Bacterial Resistance in Europe - Clostridium Difficile Infections (COMBACTE-CDI, Understanding the Burden of Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503474
• Other study ID #: IRAS244784
• Status: Completed
• Start date: June 11, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: January 2022
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3240
• Est. completion date: September 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Any repeat samples

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Enterocolitis, Pseudomembranous
• Infections

Intervention

Other:
• No intervention
There is no intervention, this is observational only

Locations

Country	Name	City	State
United Kingdom	University of Leeds	Leeds	West Yorkshire

Sponsors (15)

Lead Sponsor

Collaborator

University of Leeds

AstraZeneca, BioMérieux, Da Volterra, Eberhard Karls University of Tubingen, Germany, GlaxoSmithKline, Innovative Medicines Innitiative 2, Leiden University Medical Centre, Netherlands, National Institute for Infectious Diseases 'Lazzaro Sapllanzani', Italy, National laboratory for Health, Environment and Food, Slovenia, Pfizer ltd, Sanofi Pasteur, a Sanofi Company, Universitatsklinikum Koln, Germany, University Medical Centre Utrecht, Netherlands, University of Antwerp, Belgium

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).