Clinical trial NCT03503474: COMBACTE-CDI Understanding the Burden of C. Difficile Infection
Official title: Combatting Bacterial Resistance in Europe - Clostridium Difficile Infections (COMBACTE-CDI, Understanding the Burden of Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clostridium Difficile Infection
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: Innovative Medicines Initiative
name: UMC Utrecht
name: Leiden University Medical Center
name: National laboratory for Health, Environment and Food, Slovenia
name: Universitätsklinikum Köln
name: Universiteit Antwerpen
name: National Institute for Infectious Diseases 'Lazzaro Sapllanzani', Italy
name: Universität Tübingen
name: Pfizer
name: GlaxoSmithKline
name: BioMérieux
name: AstraZeneca
name: Sanofi Pasteur, a Sanofi Company
name: Da Volterra
First posted: 2018-04-19
Enrollment: 3240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Number of Cases of CDI
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: University of Leeds
state: West Yorkshire
Study officials:
affiliation: University of Leeds
name: Mark Wilcox, MD
role: STUDY_DIRECTOR
References: