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NCT05537896 · ClinicalTrials.gov registry record · Phase 2
Prospective Evaluation of Xerava Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia
A Phase 2 study of Neutropenia and Hematological Malignancy, sponsored by West Virginia University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT05537896 is a Phase 2 study of Neutropenia and Hematological Malignancy that is actively recruiting participants, run by West Virginia University. The registered enrollment target is 55 participants, below the 73-participant average among 12 other Neutropenia trials with a reported enrollment target (25% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05537896, a Phase 2 study of Neutropenia and Hematological Malignancy, is actively recruiting participants, sponsored by West Virginia University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Eravacycline
Study Locations (1)
West Virginia
- Aaron Cumpston - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2024-02-19 |
| Est. Completion | 2028-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05537896
The ClinicalTrials.gov registry entry for NCT05537896 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 73-participant average among 12 other Neutropenia trials with a reported enrollment target (25% lower). The listed sponsor is West Virginia University, which has 122 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Neutropenia appearing as the primary indexed condition, and to 1 intervention - of which Eravacycline is the first listed.
NCT05537896 reports 1 study location spanning 1 distinct geographic area - top geographies include West Virginia.
Frequently Asked Questions
What is clinical trial NCT05537896 about?
NCT05537896 is a clinical study titled "Prospective Evaluation of Xerava Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia". 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. Xer...
What is the current status of trial NCT05537896?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2024-02-19. Estimated completion is 2028-02.
What conditions does trial NCT05537896 study?
This clinical trial studies the following conditions: Neutropenia, Hematological Malignancy.
What interventions are being tested in trial NCT05537896?
The interventions under investigation include: Eravacycline (DRUG).
Who is sponsoring clinical trial NCT05537896?
This trial is sponsored by West Virginia University, which has 122 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05537896 being conducted?
This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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