AssessmeNT of the Incidence of Clostridium difficile Infections in hospitalized Patients on Antibiotic TrEatment
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.
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.
Promising new prevention
DAV132 is Da Volterra’s 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. The observational study ANTICIPATE aims to accelerate that development, optimally preparing for a Phase III trial with DAV132.
This observational study was conducted with 1000 patients aged over 50. They were recruited in 30 European clinical centers in the Netherlands, Germany, Greece, Spain, Romania and France. Recruited patients were followed over a three-month period to detect any occurrence of Clostridium difficile infections following antibiotic treatment. The aim is to identify the risk factors for these infections, establishing for whom the prevention of this pathology will prove the most effective.
Sponsor: University Medical Center Utrecht
EFPIA lead: Da Volterra
Academic partners: Uniklinik Köln and University of Antwerp
Study team members
Management board / EFPIA leader / DaVolterra
LAB-Net Representative / Academic / University of Antwerp
Clinical Research Associate / Academic / University Medical Center Utrecht
Study level information
- Study NO NCT02896244
- Study Name ANTICIPATE
- Study Type Observational
- Study Status Database Lock
- Enrollment Period 09/16 - 09/17
- Total subjects planned 1000
- Total subjects screened 2387
- Total subjects enrolled 1007
- Total subjects completed 1007
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- Preparation phase
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- Trial period
Country level information