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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02896244
Other study ID # COMBACTE WP7
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 27, 2016
Est. completion date March 8, 2018

Study information

Verified date May 2021
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1007
Est. completion date March 8, 2018
Est. primary completion date January 23, 2018
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: 1. Male or female hospitalized patient. 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: 1. Ongoing antibiotic treatment with one of the above classes initiated >6 hours before inclusion into the study. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention


Locations

Country Name City State
France 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
Germany 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 Munchen
Greece 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 Iráklion
Netherlands University Medical Center Utrecht
Romania 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 Iasi
Spain Bellvitge Hospital Barcelona
Spain Hospital Universitari Vall d´Hebrón Barcelona
Spain Hospital Universitario Reina Sofia Cordoba
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 Sevilla

Sponsors (4)

Lead Sponsor Collaborator
MJM Bonten Da Volterra, Universitätsklinikum Köln, Universiteit Antwerpen

Countries where clinical trial is conducted

France,  Germany,  Greece,  Netherlands,  Romania,  Spain, 

References & Publications (2)

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 dif — View Citation

van Werkhoven CH, Ducher A, Berkell M, Mysara M, Lammens C, Torre-Cisneros J, Rodríguez-Baño 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, Mentré F, Malhotra-Kum — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clostridium difficile infection 28 days
Secondary Clostridium difficile infection 90 days
Secondary Antibiotics associated diarrhea 90 days
Secondary Bacterial diversity Change from baseline to day 6 of bacterial diversity and composition of the intestinal microbiome 6 days
Secondary Urine sulfate levels Change from baseline to day 6 of 3-indoxyl sulfate levels in urine (corrected for the urine creatinine levels) 6 days
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