drugset / Trial / NCT04983901

PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN

NCT04983901

RandomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial studies the effect of imipenem-relebactam in treating patients with cancer who have a fever due to low white blood cell counts (febrile neutropenia). In this study, imipenem-relebactam will be compared to the standard-of-care treatment (cefepime, meropenem, or piperacillin/tazobactam) for the treatment of febrile neutropenia. Imipenem-relebactam is used to treat infections. Giving imipenem-relebactam may help to control febrile neutropenia in patients with cancer.

Timeline

Start
2021-09-14
Primary completion
2023-10-06
Completion
2023-10-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified Intravenous
Comparator Cefepime Small molecule Intravenous
Subject Imipenem/Cilastatin/Relebactam Unknown Intravenous
Comparator Meropenem Small molecule Intravenous
Background Daptomycin Other / unclassified Intravenous
Background Linezolid Other / unclassified Intravenous
Background Vancomycin Other / unclassified Intravenous