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NCT04673175 · ClinicalTrials.gov registry record · Phase 4
Ceftolozane-Tazobactam for Directed Treatment of Pseudomonas Aeruginosa Bacteremia and Pneumonia in Patients With Hematological Malignancies and Hematopoietic Stem Cell Transplantation
A Phase 4 study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
NCT04673175 is a Phase 4 study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 17 participants.
The verdict
NCT04673175, a Phase 4 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn whether the antibiotic ceftolozane-tazobactam works to treat serious Pseudomonas aeruginosa infections in people with blood cancers or who received a stem cell transplant. The main question it aims to answer is whether participants reach clinical success 30 days after the infection is first found. Clinical success means the person is alive, their infection symptoms are improving, and the infection has not returned. Participants will receive ceftolozane-tazobactam through a vein every 8 hours for 10 to 14 days. Treatment may continue for up to 21 days if the infection is not improving or keeps coming back. The infection is diagnosed using the hospital's standard rapid molecular tests, which help confirm Pseudomonas aeruginosa quickly so treatment can begin right away. Researchers will follow participants during their hospital stay and check on them around 30 and 60 days to see how well the treatment worked. The study will also look at how long it takes for the infection to clear, how long participants stay in the hospital or intensive care unit, and whether the bacteria become resistant to antibiotics. In addition to the prospective ceftolozane-tazobactam group, the study includes a historical control group made up of patients with similar infections who were treated in the past with standard anti-pseudomonal antibiotics (such as cefepime, ceftazidime, piperacillin-tazobactam, or meropenem). Data from these historical controls are collected by chart review and analyzed alongside the prospective group to compare outcomes. Historical controls do not receive study-directed treatment and are not actively enrolled under this protocol.
Interventions
- DRUG Ceftolozane / Tazobactam Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2023-01-10 |
| Est. Completion | 2025-03-16 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04673175
The ClinicalTrials.gov registry entry for NCT04673175 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ceftolozane / Tazobactam Injection is the first listed.
NCT04673175 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04673175 about?
NCT04673175 is a clinical study titled "Ceftolozane-Tazobactam for Directed Treatment of Pseudomonas Aeruginosa Bacteremia and Pneumonia in Patients With Hematological Malignancies and Hematopoietic Stem Cell Transplantation". The goal of this clinical trial is to learn whether the antibiotic ceftolozane-tazobactam works to treat serious Pseudomonas aeruginosa infections in people with blood cancers or who received a stem cell transplant. The main question it aims to answer is whether participants reach clinical success 3...
What is the current status of trial NCT04673175?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2023-01-10. Estimated completion is 2025-03-16.
What interventions are being tested in trial NCT04673175?
The interventions under investigation include: Ceftolozane / Tazobactam Injection (DRUG).
Who is sponsoring clinical trial NCT04673175?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
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