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NCT01969799 · ClinicalTrials.gov registry record · Phase 2

Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia

A Phase 2 study of Pneumonia, Bacterial, sponsored by Cardeas Pharma.

Completed
Registry status
Phase 2
Development phase
143
Enrollment target
20
Study locations

NCT01969799 is a Phase 2 study of Pneumonia, Bacterial that has completed, run by Cardeas Pharma. The registered enrollment target is 143 participants, below the 1,329-participant average among 7 other Pneumonia, Bacterial trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT01969799, a Phase 2 study of Pneumonia, Bacterial, has completed, sponsored by Cardeas Pharma.

COMPLETED
Registry status
Phase 2
Development phase
143 participants
Enrollment target
20
Study locations

Study Summary

To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in mechanically ventilated patients receiving IV antibiotics.

Conditions Studied

Pneumonia, Bacterial

Interventions

  • DRUG Amikacin fosfomycin inhalation solution
  • DRUG Aerosolized placebo

Study Locations (20)

Massachusetts

  • - Boston
  • - Burlington
  • - Springfield

Florida

  • - Gainesville
  • - Jacksonville

Kentucky

  • - Hazard
  • - Lexington

Texas

  • - El Paso
  • - Houston

California

  • - Los Angeles

Illinois

  • - Chicago

Michigan

  • - Detroit

Missouri

  • - St Louis

Trial Details

FieldValue
Enrollment Target 143 participants
Start Date 2013-12
Est. Completion 2016-04
Phase Phase 2

Sponsor

Cardeas Pharma

2 total trials

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What the Registry Record Tells You About NCT01969799

The ClinicalTrials.gov registry entry for NCT01969799 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,329-participant average among 7 other Pneumonia, Bacterial trials with a reported enrollment target (89% lower). The listed sponsor is Cardeas Pharma, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pneumonia, Bacterial appearing as the primary indexed condition, and to 2 interventions - of which Amikacin fosfomycin inhalation solution is the first listed.

NCT01969799 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Massachusetts, Florida, Kentucky.

Frequently Asked Questions

What is clinical trial NCT01969799 about?

NCT01969799 is a clinical study titled "Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia". To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in mechanically ventilated patients receiving IV antibiotics.

What is the current status of trial NCT01969799?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 143 participants. The study started on 2013-12. Estimated completion is 2016-04.

What conditions does trial NCT01969799 study?

This clinical trial studies the following conditions: Pneumonia, Bacterial.

What interventions are being tested in trial NCT01969799?

The interventions under investigation include: Amikacin fosfomycin inhalation solution (DRUG), Aerosolized placebo (DRUG).

Who is sponsoring clinical trial NCT01969799?

This trial is sponsored by Cardeas Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01969799 being conducted?

This trial has 20 study locations across California, Florida, Illinois, Kentucky, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.