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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 : Unknown
Verified April 2018 by Professor Mark Wilcox, University of Leeds.
Recruitment status was:  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

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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