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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 is a Phase 2 study that was terminated before completion, run by University of Florida. The registered enrollment target is 43 participants.

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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).

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

FieldValue
Enrollment Target 43 participants
Start Date 2010-09
Est. Completion 2015-04
Phase Phase 2

Sponsor

University of Florida

1,106 total trials

What the Registry Record Tells You About NCT01570192

The ClinicalTrials.gov registry entry for NCT01570192 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which IV meropenem is the first listed.

NCT01570192 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.