LAB-Net’s Role in MICROCARE

LAB-Net was involved in selecting the local laboratories, has developed a Sample Collection and Management Manual, has trained the sites on sample collection and management procedures during the first Investigator meeting held on 20 May 2021 and has provided investigational sites with all necessary materials for the collection of stool specimens. As of 31 August, site selection in Europe has been finalised, 20 sites have received supplies for sample collection and management.

LAB-Net will continue to provide sites with study material. When sample collection is up and running, samples will be shipped at regular timepoint from the local sites to the Central Laboratory where they will be further processed. Stool samples will be aliquoted and some of the aliquots will be shipped to downstream laboratories. Quantitative microbiological culture of stools will be performed at the Central Laboratory at the Laboratory of Medical Microbiology of the University of Antwerp to evaluate the presence and load of target microorganisms, for CDI assessment and for culture isolation of Clostridioides difficile from stool.

About MICROCARE

MICROCARE is a randomized, placebo-controlled, parallel-group trial. It shall enroll 900 patients newly-diagnosed with acute myeloid leukemia or high-risk myelodysplastic syndrome treated with intensive chemotherapy in approximately 70 centers worldwide.

The overarching objective of the trial is to demonstrate that the microbiome protector, DAV132, contributes to decreasing the occurrence of life-threatening complications and to reducing the mortality of patients with hematologic malignancies undergoing several cycles of chemotherapy. The trial determines whether the protection of the intestinal microbiome by DAV132 reduces the incidence of Clostridioides difficile infection (CDI) and the colonization by multidrug-resistant bacteria. Stool samples will be collected as part of the study assessments for further analysis.