Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
MDRGN, neutropenic
INFECTIOUS DISEASES
All study subjects will be screened for MDRGN gut colonization by microbiological culture at the first visit and weekly thereafter during the neutropenic period, until study completion. In each participating center, rectal exudates will be collected in ESwab™ (Copan Diagnostics Inc., Murrieta, CA) that will be sent to the microbiology laboratories for culture in selective media for MDRGN, according to the recommendations of the Spanish Society for Infectious Diseases and Clinical Microbiology (SEIMC) (22,23), specifically in CHROMagar™ The clinical trial includes a substudy in a population of 30 subjects, representative of the two treatment arms, both colonized and non-colonized according to the conventional microbiological techniques results. Two samples from each of these subjects will be recovered between those processed for culture (stored at – 80 °C) at the baseline visit and at the end of the study. In these samples, the evolution of the resistome will be investigated using “shotgun” metagenomic sequencing techniques. These results will be compared with those obtained by culture.The patient’s microbiome evolution will be studied by metataxonomic sequencing. For this purpose, a fecal sample will be collected from each study subject at the baseline visit and at the end of the study.Figure Clinical and microbiological study planning