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ANTICIPATE
Current status: Database Lock
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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.

Study information

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

  • Annie Ducher

    Management board / EFPIA leader / DaVolterra

  • Christine Lammens

    LAB-Net Representative / Academic / University of Antwerp

  • Curt Brugman

    Clinical Research Associate / Academic / UMC Utrecht

Study level information

General information
  • Study NO NCT02896244
  • Study Name ANTICIPATE
  • Study Type Observational
  • Study Status Database Lock
  • Enrollment Period 09/16 - 09/17
Enrollment
  • Total subjects planned 1000
  • Total subjects screened 2387
  • Total subjects enrolled 1007
  • Total subjects completed 1007

Study timeline

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Preparation phase
Dark blue
Trial period

Country level information

Filter
Sites planned 8
Sites activated 8
France
Subjects
planned
264
Subjects
enrolled
231
Subjects
completed
231
Subjects completed
87.5%
Sites planned 8
Sites activated 8
Germany
Subjects
planned
264
Subjects
enrolled
159
Subjects
completed
159
Subjects completed
60.2%
Sites planned 5
Sites activated 5
Greece
Subjects
planned
165
Subjects
enrolled
85
Subjects
completed
85
Subjects completed
51.5%
Sites planned 1
Sites activated 1
Netherlands
Subjects
planned
33
Subjects
enrolled
15
Subjects
completed
15
Subjects completed
45.5%
Sites planned 5
Sites activated 5
Romania
Subjects
planned
165
Subjects
enrolled
189
Subjects
completed
189
Subjects completed
114.5%
Sites planned 7
Sites activated 7
Spain
Subjects
planned
231
Subjects
enrolled
332
Subjects
completed
332
Subjects completed
143.7%