Clostridium Difficile InfectionCOMBACTE-CDINCT03503474
COMBACTE-CDI Understanding the Burden of C. Difficile Infection
An observational study of Clostridium Difficile Infection, run by University of Leeds at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Clostridium Difficile Infection
- How many people
- 3,240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jun 2018to 30 Sep 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Any repeat samples
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leeds
Leeds, West Yorkshire, LS1 3EX
About this study
Official title: Combatting Bacterial Resistance in Europe - Clostridium Difficile Infections (COMBACTE-CDI, Understanding the Burden of Disease
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
- Being tested
- No intervention
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention, this is observational only
| Study group | Role | What they receive |
|---|---|---|
| CDI cases | Not described Receives: Other: No intervention | |
| CDI negative controls | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Cases of CDI
This outcome measure is to indicate the number of participants with a sample that returned a positive test result (=CDI cases) at the coordinating laboratory from the overall total number of participants. The number of CDI cases and negative controls are the number of participants with a sample that returned a positive or negative test result, respectively. Therefore the "CDI negative controls" arm did not return a positive test result. The proportion of participants that returned a positive test result compared to the total of participants (=number of participants in the "CDI cases" arm divided by the number of total participants in both arms) can be inferred from this outcome measure.
Measured: Samples were received between July and December 2018 (at time of diarrheal episode) and test performed during that timeframe to identify the number of CDI cases (positive test result) and the number of CDI negative controls (negative test result).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start11 Jun 2018
- Primary completion31 Dec 2018
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 3,240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Innovative Medicines Initiative, UMC Utrecht, Leiden University Medical Center, National laboratory for Health, Environment and Food, Slovenia, Universitätsklinikum Köln, Universiteit Antwerpen, National Institute for Infectious Diseases 'Lazzaro Sapllanzani', Italy, Universität Tübingen, Pfizer, GlaxoSmithKline, BioMérieux, AstraZeneca, Sanofi Pasteur, a Sanofi Company, Da Volterra
- Responsible party
- Principal investigator, Professor Mark Wilcox, University of Leeds
- Investigators
- Mark Wilcox, MD, Study director, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503474
- Sponsor's protocol ID
- IRAS244784
- Acronym
- COMBACTE-CDI
- Status last verified
- Jan 2022
- First submitted
- 11 Apr 2018
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rupnik M, Viprey V, Janezic S, Tkalec V, Davis G, Sente B, Devos N, Muller BH, Santiago-Allexant E, Cleuziat P, Wilcox M, Davies K; COMBACTE-CDI consortium. Distribution of Clostridioides difficile ribotypes and sequence types across humans, animals and food in 13 European countries. Emerg Microbes Infect. 2024 Dec;13(1):2427804. doi: 10.1080/22221751.2024.2427804. Epub 2024 Nov 27.
PubMed 39535868
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combatting Bacterial Resistance in Europe - Clostridium Difficile Infections (COMBACTE-CDI, Understanding the Burden of Disease
- ClinicalTrials.gov ID
- NCT03503474
- Acronym / sponsor ID
- COMBACTE-CDI / IRAS244784
- Conditions
- Clostridium Difficile Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,240 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Innovative Medicines Initiative, UMC Utrecht, Leiden University Medical Center, National laboratory for Health, Environment and Food, Slovenia, Universitätsklinikum Köln, Universiteit Antwerpen, National Institute for Infectious Diseases 'Lazzaro Sapllanzani', Italy, Universität Tübingen, Pfizer, GlaxoSmithKline, BioMérieux, AstraZeneca, Sanofi Pasteur, a Sanofi Company, Da Volterra
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Posted 9 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDI cases | – | Other: No intervention |
| CDI negative controls | – | Other: No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Any repeat samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere is no intervention, this is observational only | Other | CDI cases, CDI negative controls |
Primary outcome
The Number of Cases of CDI
Time frame: Samples were received between July and December 2018 (at time of diarrheal episode) and test performed during that timeframe to identify the number of CDI cases (positive test result) and the number of CDI negative controls (negative test result).
This outcome measure is to indicate the number of participants with a sample that returned a positive test result (=CDI cases) at the coordinating laboratory from the overall total number of participants. The number of CDI cases and negative controls are the number of participants with a sample that returned a positive or negative test result, respectively. Therefore the "CDI negative controls" arm did not return a positive test result. The proportion of participants that returned a positive test result compared to the total of participants (=number of participants in the "CDI cases" arm divided by the number of total participants in both arms) can be inferred from this outcome measure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39535868Rupnik M, Viprey V, Janezic S, Tkalec V, Davis G, Sente B, Devos N, Muller BH, Santiago-Allexant E, Cleuziat P, Wilcox M, Davies K; COMBACTE-CDI consortium. Distribution of Clostridioides difficile ribotypes and sequence types across humans, animals and food in 13 European countries. Emerg Microbes Infect. 2024 Dec;13(1):2427804. doi: 10.1080/22221751.2024.2427804. Epub 2024 Nov 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Wilcox, MD study director
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile Infection, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Cases of CDI (time frame: Samples were received between July and December 2018 (at time of diarrheal episode) and test performed during that timeframe to identify the number of CDI cases (positive test result) and the number of CDI negative controls (negative test result).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03503474, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.