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NCT01570192 · ClinicalTrials.gov registry record · Phase 2
Clinical Trials to Reduce the Risk of Antimicrobial Resistance
A Phase 2 study, sponsored by University of Florida.
- Terminated
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT01570192: Clinical Trial Phase 2 study, sponsored by University of Florida.
NCT01570192 is a Phase 2 study that was terminated before completion, run by University of Florida. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01570192, a Phase 2 study, was terminated before completion, sponsored by University of Florida.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
The primary objective of this study is to demonstrate a low rate of emergence of antibiotic resistance in P. aeruginosa and Acinetobacter spp during the treatment of hospitalized patients with pneumonia requiring mechanical ventilation treated with PD optimized meropenem administered as a prolonged infusion in combination with a parenteral aminoglycoside plus tobramycin by inhalation (Group 1) compared to therapy with meropenem alone (Group 2 - control arm).
Primary Outcome
The emergence of resistance is defined as a change of meropenem MIC or aminoglycoside MIC by two tube dilutions (fourfold) from baseline when assessed at the second BAL procedure on day 5/early extubation. Patients are evaluable for this endpoint IF they had baseline BAL and Day 5/early extubation and if they had positive cultures on baseline and Day/EE.
Interventions
- DRUG IV meropenem
- DRUG I.V. Meropenem
- DRUG Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h
- DRUG Linezolid or Vancomycin (per institutional guidelines) will be available for MRSA coverage.
- DEVICE tobramycin nebulization
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2010-09 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
Why NCT01570192 stopped before completion
NCT01570192 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which IV meropenem is the first listed.
NCT01570192 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01570192 about?
NCT01570192 is a clinical study titled "Clinical Trials to Reduce the Risk of Antimicrobial Resistance". The primary objective of this study is to demonstrate a low rate of emergence of antibiotic resistance in P. aeruginosa and Acinetobacter spp during the treatment of hospitalized patients with pneumonia requiring mechanical ventilation treated with PD optimized meropenem administered as a prolonged ...
What is the current status of trial NCT01570192?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2010-09. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01570192?
The interventions under investigation include: IV meropenem (DRUG), I.V. Meropenem (DRUG), Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h (DRUG), Linezolid or Vancomycin (per institutional guidelines) will be available for MRSA coverage. (DRUG), tobramycin nebulization (DEVICE).
Who is sponsoring clinical trial NCT01570192?
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 NCT01570192's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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