Using Xerava to prevent infections in patients with blood cancers and low white blood cell counts
Prospective Evaluation of Xerava™ (Eravacycline) Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia
This study is testing if the antibiotic Xerava can help prevent infections in patients with blood cancers who have low white blood cell counts during their treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | West Virginia University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Morgantown, West Virginia) |
| Trial ID | NCT05537896 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the use of Xerava™ (eravacycline) as a prophylactic antibiotic in patients with hematological malignancies undergoing chemotherapy or hematopoietic stem cell transplantation who are at risk of prolonged neutropenia. The study aims to assess the incidence of breakthrough infections during eravacycline prophylaxis in this vulnerable population. Eravacycline is chosen for its broad-spectrum activity against multi-drug resistant bacteria, making it a promising alternative for infection prevention. Participants will be monitored for adverse effects and the effectiveness of the treatment in reducing infection rates.
Who should consider this trial
Good fit: Ideal candidates include patients receiving induction chemotherapy for acute leukemia or those preparing for hematopoietic stem cell transplantation with expected prolonged neutropenia.
Not a fit: Patients with uncontrolled infections, certain recent infections, or known hypersensitivity to eravacycline or related antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of infections in patients with blood cancers undergoing intensive treatment.
How similar studies have performed: While the use of eravacycline in this specific prophylactic setting is novel, similar studies have shown promise in using alternative antibiotics for infection prevention in neutropenic patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Morgantown, West Virginia
- Aaron Cumpston — Morgantown, West Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Aaron Cumpston, PharmD, BCOP — West Virginia University
- Study coordinator: Aaron Cumpston, PharmD, BCOP
- Email: cumpstona@wvumedicine.org
- Phone: 3045984000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.