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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: Recruiting Phase 2 study of Neutropenia and Hematological Malignancy, sponsored by West Virginia University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of Incidences documented that subjects had a confirmed breakthrough infection.
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 |
What NCT05537896 shows while recruiting
NCT05537896 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 73-participant average among 12 other Neutropenia trials with a reported enrollment target (25% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Neutropenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05537896's enrollment target sits among peer trials
55 5th of 12 higher than 8 of 12 other Neutropenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neutropenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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