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NCT05102162 · ClinicalTrials.gov registry record · Phase 4
BL Infusion Trial:Beta-lactam Continuous Versus Intermittent Infusion and Associated Bacterial Resistance and Therapy Outcomes in Critically Ill Patients With Severe Pneumonia
A Phase 4 study, sponsored by University of Florida.
- Terminated
- Registry status
- Phase 4
- Development phase
- 35
- Enrollment target
NCT05102162: Clinical Trial Phase 4 study, sponsored by University of Florida.
NCT05102162 is a Phase 4 study that was terminated before completion, run by University of Florida. The registered enrollment target is 35 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05102162, a Phase 4 study, was terminated before completion, sponsored by University of Florida.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 35 participants
- Enrollment target
Study Summary
The study plans to randomize a total of 240 patients infected with Gram-negative bacterial pneumonia to receive beta-lactam (meropenem, cefepime, or piperacillin/tazobactam) continuous or intermittent infusion and collect baseline and regular follow-up respiratory cultures to assess the development of new resistance. The investigators will measure beta-lactam concentration to assess the impact of drug exposure on the bacterial resistance.
Primary Outcome
Bacterial resistance is defined as new numeric increases (\>/=2 fold) in the bacterial MIC during the follow-up period compared to the baseline when starting beta-lactam therapy. MICs were collected from respiratory samples and compared from study enrollment to end of the follow-up period for at least a 2 fold increase in MIC.
Interventions
- DRUG Cefepime, Meropenem, or Piperacillin/Tazobactam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2021-12-17 |
| Est. Completion | 2023-02-28 |
| Phase | Phase 4 |
Why NCT05102162 stopped before completion
NCT05102162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Cefepime, Meropenem, or Piperacillin/Tazobactam is the first listed.
NCT05102162 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05102162 about?
NCT05102162 is a clinical study titled "BL Infusion Trial:Beta-lactam Continuous Versus Intermittent Infusion and Associated Bacterial Resistance and Therapy Outcomes in Critically Ill Patients With Severe Pneumonia". The study plans to randomize a total of 240 patients infected with Gram-negative bacterial pneumonia to receive beta-lactam (meropenem, cefepime, or piperacillin/tazobactam) continuous or intermittent infusion and collect baseline and regular follow-up respiratory cultures to assess the development ...
What is the current status of trial NCT05102162?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 35 participants. The study started on 2021-12-17. Estimated completion is 2023-02-28.
What interventions are being tested in trial NCT05102162?
The interventions under investigation include: Cefepime, Meropenem, or Piperacillin/Tazobactam (DRUG).
Who is sponsoring clinical trial NCT05102162?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05102162's enrollment target sits among peer trials
35 1506th of 2000 higher than 481 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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