RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-19
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05537896

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All patients receiving induction chemotherapy for treatment of acute leukemia or receiving preparative regimen for HSCT
  2. * Patient must provide informed consent.
  3. * Bilirubin ≤ 3 x the ULN and AST/ALT ≤ 5 x ULN
  1. * Uncontrolled bacterial, viral or fungal infection at the time of study enrollment.
  2. * Urinary tract infection receiving active treatment
  3. * Acute pancreatitis (not necessary to work-up unless symptomatic)
  4. * History of known hypersensitivity to eravacycline, tetracycline, doxycycline, minocycline, tigecycline, sarecycline, oxytetracycline, or omadacycline
  5. * Pseudomonas infection within 30 days prior to study enrollment
  6. * Receiving strong inhibitors or inducers of cytochrome P450 3A4 will be excluded from the study (see Appendix B for complete list of medications)
  7. * Pregnant or lactating women

Contacts and Locations

Study Contact

Aaron Cumpston, PharmD, BCOP
CONTACT
3045984000
cumpstona@wvumedicine.org

Principal Investigator

Aaron Cumpston, PharmD, BCOP
PRINCIPAL_INVESTIGATOR
West Virginia University

Study Locations (Sites)

Aaron Cumpston
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: West Virginia University

  • Aaron Cumpston, PharmD, BCOP, PRINCIPAL_INVESTIGATOR, West Virginia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-19
Study Completion Date2028-02

Study Record Updates

Study Start Date2024-02-19
Study Completion Date2028-02

Terms related to this study

Additional Relevant MeSH Terms

  • Hematological Malignancy
  • Neutropenia