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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Antibacterial prophylaxis is recommended in patients at high risk of infection, specifically patients undergoing acute leukemia induction therapy or hematopoietic stem cell transplant (HSCT) who are expected to have profound neutropenia (ANC\<100 neutrophils/milliliter) for more than seven days. Xerava™ (eravacycline) has a broad spectrum of activity including many multi-drug resistant strains of bacteria. It is not an agent used for treatment of febrile neutropenia, making eravacycline a very attractive alternative to consider in this prophylactic setting. Eravacycline has activity against MRSA, VRE, and Clostridioides difficile, all of which are common problems in this patient population. It also covers the majority of enteric gram-negative pathogens while also producing satisfactory tissue penetration and adequate plasma concentrations, which has classically been a concern with prior agents. Eravacycline has activity against coagulase-negative staphylococcus, which is a common catheter-related infection in leukemia and HSCT patients. The primary objective will be report the incidence of breakthrough infections during eravacycline prophylaxis for hematologic malignancy patients with prolonged neutropenia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• All patients receiving induction chemotherapy for treatment of acute leukemia or receiving preparative regimen for HSCT

• Patient must provide informed consent.

• Bilirubin ≤ 3 x the ULN and AST/ALT ≤ 5 x ULN

Locations
United States
West Virginia
Aaron Cumpston
RECRUITING
Morgantown
Contact Information
Primary
Aaron Cumpston, PharmD, BCOP
cumpstona@wvumedicine.org
3045984000
Time Frame
Start Date: 2024-02-19
Estimated Completion Date: 2028-02
Participants
Target number of participants: 55
Treatments
Experimental: Eravacycline
Eravacycline- 1 mg/kg actual body weight IV Infusion over 60 minutes every 12 hours. Alternative dosing strategy 1.5mg/kg every 12 hourse.
Sponsors
Leads: West Virginia University

This content was sourced from clinicaltrials.gov