Effectiveness of DAV132 in Clostridioides difficile infection
Research type
Research Study
Full title
A multicenter, randomized, placebo-controlled, parallel-arm clinical trial to evaluate the efficacy of DAV132 in preventing Clostridioides difficile infection in patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome treated with intensive chemotherapy
IRAS ID
289959
Contact name
Fabien Vitry
Contact email
Sponsor organisation
DA VOLTERRA
Clinicaltrials.gov Identifier
CIV-20-11-035190, Eudamed number
Duration of Study in the UK
3 years, 6 months, 0 days
Research summary
This is a pivotal study to find out how effective a medical device called DAV132 compared to a placebo, is for the prevention of Clostridioides difficile infection and the protection of the bacteria from the intestinal microbiota. This study is being done in patients with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) treated with intensive chemotherapy as both the disease and chemotherapy predispose the patients to different infections. DAV132, was designed to capture antibiotic residues in the large intestine and to protect the gut microbiota from alterations induced by antibiotics. The participants will have a 50% (1 in 2) chance of taking DAV132 or placebo. Neither the participants nor the study doctor will know which treatment the participants are assigned to. \nThe study participation will start at the beginning of the participant’s first chemotherapy. The total planned study participation is two years. The study includes two periods:\n1)\tTreatment period: the participants will receive the study treatment for a maximum duration of 4-6 months. During this period, the participants will have frequent appointments with the medical study team. The exact number of appointments will depend on the number of chemotherapy cycles the participants will have. \n2)\tLong-term follow-up period: up to two years after the start of the study treatment, during which the participants will not receive the study treatment. During this period, the investigator will collect information from the participant’s medical records to determine the long-term effects of the study treatment.\nAbout 900 patients from hospitals in Europe and North America will participate in this study.\nThe study is being sponsored by DA VOLTERRA. \n
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0120
Date of REC Opinion
1 Oct 2021
REC opinion
Favourable Opinion