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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: Completed Phase 2 study of Pneumonia, Bacterial, sponsored by Cardeas Pharma.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change from baseline in Clinical Pulmonary Infection Score (CPIS) For each patient, value obtained from a daily assessment over the 10 day study period was compared to baseline, and the LSM data represent the change from baseline data over all days. Daily CPIS will be determined by one blinded, central reviewer in order to minimize inter-observer variability. The scale ranges from 0 to 13, with 13 being the worst. The value of zero would be a healthy patient with no evidence of pneumonia. For ea
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2013-12 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
What the finished NCT01969799 record still lists
NCT01969799 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, below the 1,329-participant average among 7 other Pneumonia, Bacterial trials with a reported enrollment target (89% lower).
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 names 20 study sites across 15 states, led by 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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