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

Part of paid clinical trials in Morgantown, West Virginia.

Sponsor
West Virginia University
Study ID
NCT05537896
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Hematological Malignancy
  • Neutropenia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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)

Study Details

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.

Key Dates

Start date
Feb 19, 2024
Status verified
Apr 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Aaron CumpstonMorgantownWest Virginia26506
Aaron Cumpston, PharmD, BCOP
[email protected]
3045984000

Find similar trials in Morgantown, WV

By research site
Aaron Cumpston· Morgantown, WV

Related Studies