Prospective Evaluation of Xerava12 (Eravacycline) Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia

What this Trial Is About

This research aims to evaluate the use of Xerava12 (eravacycline) for preventing infections in patients with hematological malignancies who experience prolonged neutropenia. It focuses on individuals undergoing acute leukemia induction chemotherapy or hematopoietic stem cell transplant (HSCT) expected to have very low neutrophil counts (ANC <100 neutrophils/milliliter) for over seven days. The study is a Phase 2 trial assessing eravacycline's potential as an antibacterial prophylaxis to reduce breakthrough infections in this high-risk group. Participants will receive eravacycline intravenously at a dose of 1 mg/kg actual body weight over 60 minutes every 12 hours, with an alternative dosing option of 1.5 mg/kg every 12 hours. Treatment will continue until neutrophil recovery, febrile neutropenia, breakthrough infection, severe toxicity, or up to 21 days according to the study protocol. Eravacycline is a broad-spectrum antibiotic active against many resistant bacteria common in this population, including MRSA, VRE, and Clostridioides difficile. During the study, patients will be monitored for breakthrough infections up to 21 days, with daily tracking for adverse events during eravacycline use. Additional outcomes include infection-related and all-cause mortality up to 30 days, acute graft-versus-host disease (GVHD) up to 100 days, and measures of neutropenic fever occurrence and timing. The study includes laboratory tests to assess liver function and safety, with ongoing evaluations throughout treatment and follow-up periods.

Prospective Evaluation of Xerava Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia