COMBACTE-CDI Understanding the Burden of C. Difficile Infection

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

Interventions

OTHER

No intervention

There is no intervention, this is observational only

Sponsors & Collaborators

• Innovative Medicines Initiative

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• National laboratory for Health, Environment and Food, Slovenia

  collaborator OTHER

• Universitätsklinikum Köln

  collaborator OTHER

• Universiteit Antwerpen

  collaborator OTHER

• National Institute for Infectious Diseases 'Lazzaro Sapllanzani', Italy

  collaborator OTHER

• Universität Tübingen

  collaborator OTHER

• Pfizer

  collaborator INDUSTRY

• GlaxoSmithKline

  collaborator INDUSTRY

• BioMérieux

  collaborator INDUSTRY

• AstraZeneca

  collaborator INDUSTRY

• Sanofi Pasteur, a Sanofi Company

  collaborator INDUSTRY

• Da Volterra

  collaborator INDUSTRY

• University of Leeds

  lead OTHER

Principal Investigators

• Mark Wilcox, MD · University of Leeds

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-11

Primary Completion

2018-12-31

Completion

2019-09-30

Countries

• United Kingdom

Study Locations