Last updated on October 2017

AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment


Brief description of study

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.

Clinical Study Identifier: NCT02896244

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Henri van Werkhoven, MD, PhD

CHD Vendee
La Roche-sur-Yon, France
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Henri van Werkhoven, MD, PhD

CHU Dupuytren
Limoges, France
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Henri van Werkhoven, MD, PhD

APHP Beaujon
Paris, France
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Henri van Werkhoven, MD, PhD

APHP H pital Cochin
Paris, France
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Henri van Werkhoven, MD, PhD

H pital St Louis
Paris, France
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Henri van Werkhoven, MD, PhD

CH de Cornouaille
Quimper, France
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Henri van Werkhoven, MD, PhD

Centre Hospitalier Universitaire de Tours
Tours, France
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Henri van Werkhoven, MD, PhD

Uniklinik der RWTH
Aachen, Germany
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Henri van Werkhoven, MD, PhD

Uniklinik K ln
Cologne, Germany
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Henri van Werkhoven, MD, PhD

Universit tsklinikum Essen
Essen, Germany
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Henri van Werkhoven, MD, PhD

Universitatsklinikum Heidelberg
Heidelberg, Germany
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Henri van Werkhoven, MD, PhD

Universit tsklinikum Jena
Jena, Germany
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Henri van Werkhoven, MD, PhD

UK Leipzig
Leipzig, Germany
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Henri van Werkhoven, MD, PhD

Universit tsklinikum Schleswig-Holstein, L beck
Lübeck, Germany
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Henri van Werkhoven, MD, PhD

Klinikum der Universit t M nchen
Munchen, Germany
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Henri van Werkhoven, MD, PhD

Evangelismos General Hospital of Athens
Athens, Greece
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Henri van Werkhoven, MD, PhD

Ippokratio Hospital of Athens
Athens, Greece
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Henri van Werkhoven, MD, PhD

Laiko General Hospital
Athens, Greece
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Henri van Werkhoven, MD, PhD

University General Hospital ATTIKON
Athens, Greece
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Henri van Werkhoven, MD, PhD

University Hospital of Heraklion
Iráklion, Greece
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Lufang Zhang, MD

University Medical Center
Utrecht, Netherlands
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Henri van Werkhoven, MD, PhD

Infectious and Tropical Diseases Hospital "Dr. Victor Babes"
Bucharest, Romania
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Henri van Werkhoven, MD, PhD

The National Institute of Infectious Diseases Matei Bals
Bucharest, Romania
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Henri van Werkhoven, MD, PhD

Cluj Napoca Infectious disease Clinical Hospital
Cluj Napoca, Romania
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Henri van Werkhoven, MD, PhD

Oncology Institute Ion Chiricuta Cluj Napoca
Cluj Napoca, Romania
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Henri van Werkhoven, MD, PhD

Clinical Hospital Of Infectious Diseases Of Iasi
Iasi, Romania
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Henri van Werkhoven, MD, PhD

Bellvitge Hospital
Barcelona, Spain
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Henri van Werkhoven, MD, PhD

Hospital Universitari Vall d Hebr n
Barcelona, Spain
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Henri van Werkhoven, MD, PhD

Hospital Universitario Reina Sofia
Cordoba, Spain
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Henri van Werkhoven, MD, PhD

Hospital Universitario 12 de Octubre
Madrid, Spain
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Henri van Werkhoven, MD, PhD

Hospital Universitario Gregorio Mara on
Madrid, Spain
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Henri van Werkhoven, MD, PhD

Hospital Universitario Ram n y Cajal
Madrid, Spain
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Henri van Werkhoven, MD, PhD

Hospital Universitario Virgen Macarena
Sevilla, Spain
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