AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment
ANTICIPATE
1 other identifier
observational
1,007
6 countries
34
Brief Summary
During or after antibiotic treatment, antibiotic residues impair the intestinal microbiota (gut flora) and lead to adverse effects such as the emergence of bacterial resistance or the occurrence antibiotic-associated diarrhoea (AAD) including antibiotic-induced C. difficile infection (CDI). The spread of resistant Gram-negative bacteria and the increasing number and severity of CDI are considered as worldwide public health threats. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2016
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2016
CompletedFirst Posted
Study publicly available on registry
September 12, 2016
CompletedStudy Start
First participant enrolled
September 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2018
CompletedMay 21, 2021
May 1, 2021
1.3 years
September 6, 2016
May 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clostridium difficile infection
28 days
Secondary Outcomes (4)
Clostridium difficile infection
90 days
Antibiotics associated diarrhea
90 days
Bacterial diversity
6 days
Urine sulfate levels
6 days
Interventions
Eligibility Criteria
Patients aged 50 or older receiving oral or intervenous antibiotic treatment with Third or fourth generation cephalosporins, Fluoroquinolones, Penicillins +beta-lactamase inhibitors, Clindamycin, or Carbapenems during hospitalization.
You may qualify if:
- Male or female hospitalized patient.
- Aged ≥ 50 years old.
- 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
You may not qualify if:
- Patient with stoma.
- Subject has been included into this study previously.
- Patient treated with probiotics to prevent CDI.
- 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.
- Subject is subject to legal protection.
- Subject deprived of liberty by judicial or administrative decision.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MJM Bontenlead
- Da Volterracollaborator
- Universitätsklinikum Kölncollaborator
- Universiteit Antwerpencollaborator
Study Sites (34)
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
Related Publications (2)
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.
PMID: 33854064RESULTBerkell 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.
PMID: 33854066RESULT
Related Links
Biospecimen
Bacterial DNA from rectal swab samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Bonten, MD, PhD
UMC Utrecht
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of molecular epidemiology of infectious diseases, head of department of medical microbiology
Study Record Dates
First Submitted
September 6, 2016
First Posted
September 12, 2016
Study Start
September 27, 2016
Primary Completion
January 23, 2018
Study Completion
March 8, 2018
Last Updated
May 21, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share
16S rRNA and shotgun metagenomic sequence data generated and analyzed in this study have been deposited in the NCBI Sequence Read Archive with the accession code PRJNA685914. Human reads were identified and removed prior to shotgun metagenomics data upload. Access to clinical data is restricted as the informed consent provided does not allow for use of clinical data outside the research institution. Data are available from the corresponding author upon reasonable requests.