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.
- Other: no intervention
|Ages eligible for Study||50 Years and older|
|Genders eligible for Study||All|
|Accepts Healthy Volunteers||No|
- 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
- Penicillins +beta-lactamase inhibitors
- Written informed consent provided prior to inclusion.
- Ongoing antibiotic treatment with one of the above classes initiated >6 hours before inclusion into the study.
- ICU admission at the time of inclusion or anticipated admission within 48h.
- Suspected or diagnosed CDI, ongoing treatment for CDI, or diarrhoea at the time of inclusion.
- 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.
- CHD VendeerecruitingLa Roche-sur-Yon, France
- CHU DupuytrenrecruitingLimoges, France
- APHP BeaujonrecruitingParis, France
- APHP BichatrecruitingParis, France
- APHP Hôpital CochinrecruitingParis, France
- Hôpital St LouisrecruitingParis, France
- CH de CornouaillerecruitingQuimper, France
- Centre Hospitalier Universitaire de ToursrecruitingTours, France
- Uniklinik der RWTHnot yet recruitingAachen, Germany
- Uniklinik KölnrecruitingCologne, Germany
- Universitätsklinikum EssenrecruitingEssen, Germany
- Universitatsklinikum HeidelbergrecruitingHeidelberg, Germany
- Universitätsklinikum JenarecruitingJena, Germany
- UK LeipzigrecruitingLeipzig, Germany
- Universitätsklinikum Schleswig-Holstein, LübeckrecruitingLübeck, Germany
- Klinikum der Universität MünchenrecruitingMunchen, Germany
- Evangelismos General Hospital of AthensrecruitingAthens, Greece
- Ippokratio Hospital of Athensnot yet recruitingAthens, Greece
- Laiko General HospitalrecruitingAthens, Greece
- University General Hospital ATTIKONrecruitingAthens, Greece
- University Hospital of HeraklionrecruitingIráklion, Greece
- University Medical CenterrecruitingUtrecht, Netherlands
- Infectious and Tropical Diseases Hospital "Dr. Victor Babes"recruitingBucharest, Romania
- The National Institute of Infectious Diseases Matei BalsrecruitingBucharest, Romania
- Cluj Napoca Infectious disease Clinical HospitalrecruitingCluj Napoca, Romania
- Oncology Institute Ion Chiricuta Cluj NapocarecruitingCluj Napoca, Romania
- Clinical Hospital Of Infectious Diseases Of IasirecruitingIasi, Romania
- Bellvitge HospitalrecruitingBarcelona, Spain
- Hospital Universitari Vall d´HebrónrecruitingBarcelona, Spain
- Hospital Universitario Reina SofiarecruitingCordoba, Spain
- Hospital Universitario 12 de OctubrerecruitingMadrid, Spain
- Hospital Universitario Gregorio MarañonrecruitingMadrid, Spain
- Hospital Universitario Ramón y CajalrecruitingMadrid, Spain
- Hospital Universitario Virgen MacarenarecruitingSevilla, Spain
26 September, 2016
10 October, 2017