Last updated on May 2018

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

Henri van Werkhoven, MD, PhD

CHU Dupuytren
Limoges, France

Henri van Werkhoven, MD, PhD

APHP Beaujon
Paris, France

Henri van Werkhoven, MD, PhD

APHP Bichat
Paris, France

Henri van Werkhoven, MD, PhD

APHP H pital Cochin
Paris, France

Henri van Werkhoven, MD, PhD

H pital St Louis
Paris, France

Henri van Werkhoven, MD, PhD

CH de Cornouaille
Quimper, France

Henri van Werkhoven, MD, PhD

Centre Hospitalier Universitaire de Tours
Tours, France

Henri van Werkhoven, MD, PhD

Uniklinik der RWTH
Aachen, Germany

Henri van Werkhoven, MD, PhD

Uniklinik K ln
Cologne, Germany

Henri van Werkhoven, MD, PhD

Universit tsklinikum Essen
Essen, Germany

Henri van Werkhoven, MD, PhD

Universitatsklinikum Heidelberg
Heidelberg, Germany

Henri van Werkhoven, MD, PhD

Universit tsklinikum Jena
Jena, Germany

Henri van Werkhoven, MD, PhD

UK Leipzig
Leipzig, Germany

Henri van Werkhoven, MD, PhD

Klinikum der Universit t M nchen
Munchen, Germany

Henri van Werkhoven, MD, PhD

Evangelismos General Hospital of Athens
Athens, Greece

Henri van Werkhoven, MD, PhD

Ippokratio Hospital of Athens
Athens, Greece

Henri van Werkhoven, MD, PhD

Laiko General Hospital
Athens, Greece

Henri van Werkhoven, MD, PhD

University General Hospital ATTIKON
Athens, Greece

Lufang Zhang, MD

University Medical Center
Utrecht, Netherlands

Henri van Werkhoven, MD, PhD

Infectious and Tropical Diseases Hospital "Dr. Victor Babes"
Bucharest, Romania

Henri van Werkhoven, MD, PhD

The National Institute of Infectious Diseases Matei Bals
Bucharest, Romania

Henri van Werkhoven, MD, PhD

Cluj Napoca Infectious disease Clinical Hospital
Cluj Napoca, Romania

Henri van Werkhoven, MD, PhD

Oncology Institute Ion Chiricuta Cluj Napoca
Cluj Napoca, Romania

Henri van Werkhoven, MD, PhD

Clinical Hospital Of Infectious Diseases Of Iasi
Iasi, Romania

Henri van Werkhoven, MD, PhD

Bellvitge Hospital
Barcelona, Spain

Henri van Werkhoven, MD, PhD

Hospital Universitari Vall d Hebr n
Barcelona, Spain

Henri van Werkhoven, MD, PhD

Hospital Universitario Reina Sofia
Cordoba, Spain

Henri van Werkhoven, MD, PhD

Hospital Universitario 12 de Octubre
Madrid, Spain

Henri van Werkhoven, MD, PhD

Hospital Universitario Gregorio Mara on
Madrid, Spain

Henri van Werkhoven, MD, PhD

Hospital Universitario Ram n y Cajal
Madrid, Spain

Henri van Werkhoven, MD, PhD

Hospital Universitario Virgen Macarena
Sevilla, Spain

Henri van Werkhoven, MD, PhD

Universit tsklinikum Schleswig-Holstein, L beck
Lübeck, Germany

Henri van Werkhoven, MD, PhD

University Hospital of Heraklion
Iráklion, Greece