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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: Clinical Trial Phase 4 study, sponsored by Weill Medical College of Cornell University.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Clinical success 30 days after collection of the index culture. Clinical success is defined as meeting all of the following criteria at that time point: survival; resolution or near resolution of baseline clinical manifestations, including fever, hypoxia, and signs or symptoms of sepsis; and absence of recurrent infection due to Pseudomonas aeruginosa or persistent infection despite more than 7 days of anti-pseudomonal therapy.
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 |
Why NCT04673175 stopped before completion
NCT04673175 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Ceftolozane / Tazobactam Injection is the first listed.
NCT04673175 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04673175's enrollment target sits among peer trials
17 1854th of 2000 higher than 132 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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