COMBACTE-CDI Understanding the Burden of C. Difficile Infection

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-11

Study Completion Date

2019-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Clostridium Difficile Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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CDI cases

No intervention

Intervention Type OTHER

There is no intervention, this is observational only

CDI negative controls

No intervention

Intervention Type OTHER

There is no intervention, this is observational only

Interventions

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No intervention

There is no intervention, this is observational only

Intervention Type OTHER

Eligibility Criteria

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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