NCT05537896 Prospective Evaluation of Xerava Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia
| NCT ID | NCT05537896 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | West Virginia University |
| Condition | Hematological Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2024-02-19 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 55 participants in total. It began in 2024-02-19 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Aaron Cumpston, PharmD, BCOP
PRINCIPAL INVESTIGATOR
West Virginia University
Frequently Asked Questions
Who can join the NCT05537896 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematological Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05537896 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05537896 currently recruiting?
Yes, NCT05537896 is actively recruiting participants. Contact the research team at cumpstona@wvumedicine.org for enrollment information.
Where is the NCT05537896 trial being conducted?
This trial is being conducted at Morgantown, United States.
Who is sponsoring the NCT05537896 clinical trial?
NCT05537896 is sponsored by West Virginia University. The principal investigator is Aaron Cumpston, PharmD, BCOP at West Virginia University. The trial plans to enroll 55 participants.