RecruitingPhase 2NCT05537896

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

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


Sponsor

West Virginia University

Enrollment

55 participants

Start Date

Feb 19, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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

Exclusion Criteria7

  • Uncontrolled bacterial, viral or fungal infection at the time of study enrollment.
  • Urinary tract infection receiving active treatment
  • Acute pancreatitis (not necessary to work-up unless symptomatic)
  • History of known hypersensitivity to eravacycline, tetracycline, doxycycline, minocycline, tigecycline, sarecycline, oxytetracycline, or omadacycline
  • Pseudomonas infection within 30 days prior to study enrollment
  • Receiving strong inhibitors or inducers of cytochrome P450 3A4 will be excluded from the study (see Appendix B for complete list of medications)
  • Pregnant or lactating women

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Interventions

DRUGEravacycline

Eravacycline will be continued until one of the following criteria is met: * neutrophil recovery (ANC \>500, post-nadir) * febrile neutropenia * breakthrough infection * any grade 3-4 toxicity related to eravacycline use * 21 days of therapy (maximum duration allowed per study protocol)


Locations(1)

Aaron Cumpston

Morgantown, West Virginia, United States

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NCT05537896


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