Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05537896

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

Led by West Virginia University · Updated on 2026-04-16

55

Participants Needed

1

Research Sites

206 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients receiving induction chemotherapy for acute leukemia or preparative regimen for hematopoietic stem cell transplant
  • Patient must provide informed consent
  • Bilirubin less than or equal to 3 times the upper limit of normal
  • AST and ALT less than or equal to 5 times the upper limit of normal
Not Eligible

You will not qualify if you...

  • Uncontrolled bacterial, viral, or fungal infection at enrollment
  • Active treatment for urinary tract infection
  • Acute pancreatitis unless symptomatic
  • Known allergy to eravacycline or related tetracycline antibiotics
  • Pseudomonas infection within 30 days before enrollment
  • Use of strong cytochrome P450 3A4 inhibitors or inducers
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Aaron Cumpston

Morgantown, West Virginia, United States, 26506

Actively Recruiting

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Research Team

A

Aaron Cumpston, PharmD, BCOP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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