Current status: Completed

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ANTICIPATE

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 / Universiteit Antwerpen
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

Light blue: Preparation phase
Dark blue: Trial period

Country level information

Filter

Sites planned 8

Sites activated 8

Subjects
planned 264

Subjects
enrolled 231

Subjects
completed 231

Subjects completed

87.5%

Sites planned 8

Sites activated 8

Subjects
planned 264

Subjects
enrolled 159

Subjects
completed 159

Subjects completed

60.2%

Sites planned 5

Sites activated 5

Subjects
planned 165

Subjects
enrolled 85

Subjects
completed 85

Subjects completed

51.5%

Sites planned 1

Sites activated 1

Subjects
planned 33

Subjects
enrolled 15

Subjects
completed 15

Subjects completed

45.5%

Sites planned 5

Sites activated 5

Subjects
planned 165

Subjects
enrolled 189

Subjects
completed 189

Subjects completed

114.5%

Sites planned 7

Sites activated 7

Subjects
planned 231

Subjects
enrolled 332

Subjects
completed 332

Subjects completed

143.7%

07/12/2023

Important Pieces Of A Puzzle

09/11/2023

The rise of Clostridium difficile

Promising new prevention

Study information

Study team members

Annie Ducher

Christine Lammens

Curt Brugman

Study level information

Study timeline

Country level information

Important Pieces Of A Puzzle

Reflections On COMBACTE-NET