ANTICIPATE Study Completes Observational Phase

The ANTICIPATE study performed their Last Patient Last Visit (LPLV) on the 18th of January.

Currently, sites are working on retrieving the observational information from their patients and getting the data entered in the eCRF system in order to have all queries resolved. The aim is to have a Data Base Lock on March 8^th 2018 after which analysis of the study will start.

All 1000 recruited patients (in 30 European clinical centers in the Netherlands, Germany, Greece, Spain, Romania and France), over the age of 50 were observed for a three month period to detect any occurrence of Clostridium difficile infections following antibiotic treatment. The aim was to identify the risk factors for these infections, establishing for whom the prevention of this pathology will prove the most effective.

The ANTICIPATE team has submitted an abstract on ‘Incidence and predictive biomarkers of antibiotic-associated diarrhea and Clostridium difficile infection’ to ECCMID 2018, and are happy to announce that it has been accepted and will be presented as a poster.

The rise of Clostridium difficile

Clostridium difficile infections spread in the environment via infected individuals with intestinal flora disrupted by antibiotic treatment. During the last decade the number of infections has increased rapidly, leading to growing concern across the world. Centers for disease control and prevention (CDCs) estimated that Clostridium difficile causes 500,000 infections and 29,000 deaths each year in the United States alone. At a cost of over $4 billion. In Europe, the rise of Clostridium difficile is just as worrying. Costing society an estimated €3 billion a year.

About ANTICIPATE:

ANTICIPATE is an observational, epidemiological study involving hospitalized patients undergoing oral or intravenous broad-spectrum antibiotics treatments. The study aims to determine the incidence of Clostridium difficile infections and to better prevent this severe pathology. It is being conducted in close collaboration with Da Volterra.

Da Volterra’s, DAV132 is promising new therapeutic agent for the prevention of Clostridium difficile infections in high-risk patients. It is currently in the stage of clinical development. The product protects the intestinal microbiota from antibiotics-induced alterations.

ANTICIPATE aims to accelerate that development, optimally preparing for a Phase III trial with DAV132.