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

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ClinicalTrials.gov Identifier: NCT03503474
Recruitment Status : Not yet recruiting
First Posted : April 19, 2018
Last Update Posted : April 19, 2018
Sponsor:
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

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.


Condition or disease Intervention/treatment
Clostridium Difficile Infection Other: No intervention

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Study Type : Observational
Estimated Enrollment : 3240 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Combatting Bacterial Resistance in Europe - Clostridium Difficile Infections (COMBACTE-CDI, Understanding the Burden of Disease
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : October 2020

Group/Cohort Intervention/treatment
CDI cases Other: No intervention
There is no intervention, this is observational only

CDI negative controls Other: No intervention
There is no intervention, this is observational only




Primary Outcome Measures :
  1. The number of cases of CDI [ Time Frame: 3 years ]

Biospecimen Retention:   Samples Without DNA
residual diagnostic faecal samples


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503474


Contacts
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Contact: Mark Wilcox, MD +441133926818 mark.wilcox@nhs.net
Contact: Kerrie Davies, MSc +441133928664 kerrie.davies@nhs.net

Locations
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United Kingdom
University of Leeds Not yet recruiting
Leeds, West Yorkshire, United Kingdom, LS1 3EX
Contact: Mark Wilcox, MD    +44113 3926818    mark.wilcox@nhs.net   
Sponsors and Collaborators
University of Leeds
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
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Study Director: Mark Wilcox, MD University of Leeds

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Responsible Party: Professor Mark Wilcox, Brotherton Chair of Microbiology, University of Leeds
ClinicalTrials.gov Identifier: NCT03503474     History of Changes
Other Study ID Numbers: IRAS244784
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections