This phase IV trial compares the effectiveness of two antimicrobial drugs, meropenem and micafungin, for improving febrile neutropenia in patients with hematologic malignancies. Febrile neutropenia presents when patients have a fever and a low number of immune cells called neutrophils to fight off infection. Meropenem is an antibiotic used to treat infections caused by bacteria. Micafungin is an antifungal used to treat fungal infections by stopping fungal growth. Both meropenem and micafungin are approved by the Food and Drug Association to treat infections. This trial evaluates whether one of these drugs is more effective than the other at improving febrile neutropenia in patients with hematologic malignancies.
Additional locations may be listed on ClinicalTrials.gov for NCT05784844.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To compare the clinical efficacy of two approaches to antimicrobial revision among patients with persistent febrile neutropenia to determine the global success rate.
SECONDARY OBJECTIVES:
I. To compare two approaches to antimicrobial revision among patients with persistent febrile neutropenia in regards to:
Ia. In-hospitality mortality or discharge to hospice;
Ib. Hospital length of stay;
Ic. Time to defervescence;
Id. Days of therapy with meropenem or micafungin;
Ie. Rate of Clostridioides difficile infection on meropenem or micafungin;
If. Cause of any proven breakthrough infection while on meropenem or micafungin.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive meropenem intravenously (IV) every 8, 12, or 24 hours depending on renal function from day 1 until discharge from the hospital in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive micafungin IV every 24 hours from day 1 until discharge from the hospital in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 24-96 hours.
Trial PhasePhase IV
Trial Typesupportive care
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorJohn Williamson
