AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment
NCT ID: NCT02896244
Last Updated: 2021-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1007 participants
OBSERVATIONAL
2016-09-27
2018-03-08
Brief Summary
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Da Volterra is a biotechnology company developing a novel product, DAV132 (a medical device in Europe), intended to prevent these antibiotic adverse effects. Da Volterra is planning to carry out a phase 2-3 randomized controlled trial (RCT) of DAV132 in the prevention of antibiotic-induced CDI. The RCT will involve hospitalized patients aged ≥50 years old and treated with predefined antibiotic classes known to increase the risk of CDI. The incidence of CDI in this population is unknown, yet, incidence is an important determinant for the required sample size.
Therefore, the main objective of the current study is to assess CDI incidence in patients ≥50 years of age treated with predefined antibiotic classes.
In addition, to optimise the target population of the DAV132 RCT, the effect of the predefined antibiotic agents on the intestinal microbiota will be assessed. Furthermore, biomarkers predictive of CDI occurrence might help identify patients at high risk for the disease, which could further optimise the RCT. No validated biomarkers have been described in the literature yet. Assessment of potential biomarkers is another aim of the present study.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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no intervention
Eligibility Criteria
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Inclusion Criteria
2. Aged ≥ 50 years old.
3. Initiation of intravenous or oral treatment with intended duration ≥5 days (≥1 day for clindamycin) with at least one of the following antibiotic classes, or treatment scheduled within the next 72 hours:
* Third or fourth generation cephalosporins
* Fluoroquinolones
* Penicillins +beta-lactamase inhibitors
* Clindamycin
* Carbapenems
4. Written informed consent provided prior to inclusion.
Exclusion Criteria
2. ICU admission at the time of inclusion or anticipated admission within 48h.
3. Suspected or diagnosed CDI, ongoing treatment for CDI, or diarrhoea at the time of inclusion.
4. Patient with stoma.
5. Subject has been included into this study previously.
6. Patient treated with probiotics to prevent CDI.
7. Patient with any social or logistical condition which in the opinion of the investigator may interfere with the conduct of the study, such as incapacity to well understand, not willing to collaborate, or cannot easily be contacted after discharge.
8. Subject is subject to legal protection.
9. Subject deprived of liberty by judicial or administrative decision.
50 Years
ALL
No
Sponsors
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Da Volterra
INDUSTRY
Universitätsklinikum Köln
OTHER
Universiteit Antwerpen
OTHER
MJM Bonten
OTHER
Responsible Party
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MJM Bonten
Professor of molecular epidemiology of infectious diseases, head of department of medical microbiology
Principal Investigators
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Marc Bonten, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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CHD Vendee
La Roche-sur-Yon, , France
CHU Dupuytren
Limoges, , France
APHP Beaujon
Paris, , France
APHP Bichat
Paris, , France
APHP Hôpital Cochin
Paris, , France
Hôpital St Louis
Paris, , France
CH de Cornouaille
Quimper, , France
Centre Hospitalier Universitaire de Tours
Tours, , France
Uniklinik der RWTH
Aachen, , Germany
Uniklinik Köln
Cologne, , Germany
Universitätsklinikum Essen
Essen, , Germany
Universitatsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinikum Jena
Jena, , Germany
UK Leipzig
Leipzig, , Germany
Universitätsklinikum Schleswig-Holstein, Lübeck
Lübeck, , Germany
Klinikum der Universität München
München, , Germany
Evangelismos General Hospital of Athens
Athens, , Greece
Ippokratio Hospital of Athens
Athens, , Greece
Laiko General Hospital
Athens, , Greece
University General Hospital ATTIKON
Athens, , Greece
University Hospital of Heraklion
Irakleio, , Greece
University Medical Center
Utrecht, , Netherlands
Infectious and Tropical Diseases Hospital "Dr. Victor Babes"
Bucharest, , Romania
The National Institute of Infectious Diseases Matei Bals
Bucharest, , Romania
Cluj Napoca Infectious disease Clinical Hospital
Cluj-Napoca, , Romania
Oncology Institute Ion Chiricuta Cluj Napoca
Cluj-Napoca, , Romania
Clinical Hospital Of Infectious Diseases Of Iasi
Iași, , Romania
Bellvitge Hospital
Barcelona, , Spain
Hospital Universitari Vall d´Hebrón
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Countries
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References
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van Werkhoven CH, Ducher A, Berkell M, Mysara M, Lammens C, Torre-Cisneros J, Rodriguez-Bano J, Herghea D, Cornely OA, Biehl LM, Bernard L, Dominguez-Luzon MA, Maraki S, Barraud O, Nica M, Jazmati N, Sablier-Gallis F, de Gunzburg J, Mentre F, Malhotra-Kumar S, Bonten MJM, Vehreschild MJGT; ANTICIPATE Study Group. Incidence and predictive biomarkers of Clostridioides difficile infection in hospitalized patients receiving broad-spectrum antibiotics. Nat Commun. 2021 Apr 14;12(1):2240. doi: 10.1038/s41467-021-22269-y.
Berkell M, Mysara M, Xavier BB, van Werkhoven CH, Monsieurs P, Lammens C, Ducher A, Vehreschild MJGT, Goossens H, de Gunzburg J, Bonten MJM, Malhotra-Kumar S; ANTICIPATE study group. Microbiota-based markers predictive of development of Clostridioides difficile infection. Nat Commun. 2021 Apr 14;12(1):2241. doi: 10.1038/s41467-021-22302-0.
Related Links
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COMBACTE consortium website: ANTICIPATE is WP7 of COMBACTE
Other Identifiers
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COMBACTE WP7
Identifier Type: -
Identifier Source: org_study_id
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