Getting Familiar with CDI
Marlieke De Kraker, project coordinator of STAT-Net, is not doing research within COMBACTE-CDI, but she is not unfamiliar with Clostridioides Difficile Infection (CDI). Now the oppurtunity arose to do research on CDI by participating in the newer COMBACTE-NET study MICROCARE. During the C. difficile Awareness Month we asked her about her ideas on CDI and the MICROCARE.
Overuse of antibiotics is a huge problem, which feeds the silent pandemic of antimicrobial resistance. This is even more relevant now that we are facing a global, viral pandemic, which risks an even larger overuse or misuse of antibiotics. In my career, I have mainly focused on the health and economic burden of drug-resistant infections, but clearly the impact of antibiotic overuse is much wider, and also includes the risk of C. difficile infections (CDI).
Being part of COMBACTE-Net, has provided me with the opportunity to learn more about this disease, which has high re-infection rates and associated re-hospitalizations. For patients it is a debilitating disease, even more so, because it often affects already vulnerable patients, whose mortality risk will be even higher due to a disease that might have been preventable.
Current therapeutic approaches consist of antibiotic therapy, which often fail, or faecal microbiota transplantation, which is far from standard and difficult to safely implement. That is why it is very inspiring to work within a public-private partnership dedicated to bring a safe, and easy alternative to the market that could prevent CDI.
Together with Da Volterra and academic partners from COMBACTE-Net, we are currently setting up a phase III trial, MICROCARE, to test the efficacy of their product in reducing the incidence of CDI in a high-risk population.
“The treatment tested in MICROCARE could have an even broader impact in the battle against antimicrobial resistance through its effects on the patient’s microbiome, a very exciting prospective!”
MICROCARE
COMBACTE-NET’s work package 7B is a Phase 3 study recently named MICROCARE. MICROCARE aims to demonstrate the efficacy of DAV132, a microbiota-protective therapy developed by Da Volterra, in preventing the occurrence of Clostridioides difficile infection (CDI) in patients with newly diagnosed Acute Myeloid Leukemia (AML) or high risk Myelodysplatic Syndrome treated with intensive chemotherapy. MICROCARE will be a multicenter study across Europe and North America to recruit 900 patients starting soon.
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