COMBACTE-CDI Understanding the Burden of C. Difficile Infection (COMBACTE-CDI)

• ClinicalTrials.gov Identifier: NCT03503474
• Recruitment Status: Unknown
• First Posted: April 19, 2018
• Last Update Posted: April 19, 2018
• Sponsor: University of Leeds
• Collaborators: Innovative Medicines Innitiative 2; University Medical Centre Utrecht, Netherlands; Leiden University Medical Centre, Netherlands; National laboratory for Health, Environment and Food, Slovenia; Universitatsklinikum Koln, Germany; University of Antwerp, Belgium; National Institute for Infectious Diseases 'Lazzaro Sapllanzani', Italy; Eberhard Karls University of Tubingen, Germany; Pfizer ltd; GlaxoSmithKline; BioMérieux; AstraZeneca; Sanofi Pasteur, a Sanofi Company; Da Volterra
• Information provided by (Responsible Party): Professor Mark Wilcox, University of Leeds

Tracking Information

• First Submitted Date: April 11, 2018
• First Posted Date: April 19, 2018
• Last Update Posted Date: April 19, 2018
• Estimated Study Start Date: May 2018
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 11, 2018): The number of cases of CDI [ Time Frame: 3 years ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Other
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

residual diagnostic faecal samples

• 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
• Condition: Clostridium Difficile Infection

Intervention

Other: No intervention

There is no intervention, this is observational only

Study Groups/Cohorts

• CDI cases
  Intervention: Other: No intervention
• CDI negative controls
  Intervention: Other: No intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 11, 2018): 3240
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2020
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT03503474
• Other Study ID Numbers: IRAS244784
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Professor Mark Wilcox, University of Leeds
• Study Sponsor: University of Leeds

Collaborators

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

Investigators

• Study Director: Mark Wilcox, MD; University of Leeds

• PRS Account: University of Leeds
• Verification Date: April 2018