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

NCT ID: NCT05537896

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-19
• Study Completion Date: 2028-02-29

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.

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.

Conditions

Hematological Malignancy; Neutropenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Eravacycline

Intervention Type: 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)

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)

Intervention Type: DRUG

Other Intervention Names

Xerava

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Aaron Cumpston, PharmD, BCOP

Pharmacy Clinical Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aaron Cumpston, PharmD, BCOP

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

Aaron Cumpston

Morgantown, West Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Aaron Cumpston, PharmD, BCOP

Role: CONTACT

cumpstona@wvumedicine.org

3045984000 ext. 73350

Facility Contacts

Aaron Cumpston, PharmD, BCOP

Role: primary

cumpstona@wvumedicine.org

304-598-4000

Other Identifiers

2206591296

Identifier Type: -

Identifier Source: org_study_id