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

NCT05537896 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2206591296
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Documented Breakthrough Infections

  Number of Incidences documented that subjects had a confirmed breakthrough infection.

  Up to 21 days

Secondary Outcomes (6)

• Adverse Events

  Daily during Eravacycline

• Infection-related mortality

  Up to 30 days

• All-cause mortality

  Up to 30 days

• Acute GVHD

  Up to 100 days

• Neutropenic fever

  Up to 21 days

Study Arms (1)

Eravacycline

EXPERIMENTAL

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

Drug: Eravacycline

Interventions

Eravacycline DRUG

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)

Also known as: Xerava

Eravacycline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

Aaron Cumpston

Morgantown, West Virginia, 26506, United States

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Neutropenia

Interventions

eravacycline

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders

Study Officials

• Aaron Cumpston, PharmD, BCOP

  West Virginia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron Cumpston, PharmD, BCOP

CONTACT

3045984000; cumpstona@wvumedicine.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacy Clinical Specialist

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 13, 2022
• Study Start: February 19, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)