Recruiting
Phase 2

Xerava

Sponsor:

West Virginia University

Code:

NCT05537896

Conditions

Hematological Malignancy

Neutropenia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Eravacycline

Study Details

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.

Conditions

Hematological Malignancy

Neutropenia

Study ID

NCT05537896

Start date

Feb 19, 2024

Status verified date

Apr, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

55 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Eravacycline

Eravacycline- 1 mg/kg actual body weight IV Infusion over 60 minutes every 12 hours. Alternative dosing strategy 1.5mg/kg every 12 hourse.

Interventions

Eravacycline

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)

Primary outcome measure

  • Incidence of Documented Breakthrough Infections [ Time Frame: Up to 21 days ]

Central Contacts and Locations

Central contacts

Aaron Cumpston, PharmD, BCOP

3045984000cumpstona@wvumedicine.org

Locations

Aaron Cumpston

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Aaron Cumpston, PharmD, BCOP

3045984000cumpstona@wvumedicine.org

More Information

Sponsor

West Virginia University

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by West Virginia University on 2026-04-16.