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

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

NCT ID: NCT05537896

Condition: Hematological Malignancy
Neutropenia

Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Neutropenia

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Eravacycline
Description: 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)
Arm group label: Eravacycline

Other name: Xerava

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.

Detailed 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) is a synthetic halogenated tetracycline class antibiotic, with 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. Adverse effects with this agent are minimal including infusion site reactions and gastrointestinal disorders. 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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Aaron Cumpston

Address:
City: Morgantown
Zip: 26506
Country: United States

Status: Recruiting

Contact:
Last name: Aaron Cumpston, PharmD, BCOP

Phone: 304-598-4000
Email: cumpstona@wvumedicine.org

Start date: February 19, 2024

Completion date: February 2028

Lead sponsor:
Agency: West Virginia University
Agency class: Other

Source: West Virginia University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05537896