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NCT01799993 · ClinicalTrials.gov registry record · Phase 3
Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 725
- Enrollment target
NCT01799993: Completed Phase 3 study, sponsored by Bayer.
NCT01799993 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 725 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01799993, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 725 participants
- Enrollment target
Study Summary
To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System (PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal saline) administered as an aerosol by the PDDS Clinical every 12 hours, in intubated and mechanically-ventilated patients with Gram-negative Pneumonia. The secondary endpoint objectives are to evaluate the superiority of aerosolized BAY 41-6551 versus aerosolized placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on ventilation, and the days in the intensive care unit (ICU).
Primary Outcome
The primary efficacy variable is Survival through the late follow-up (LFU) visit. Survival is achieved when the participant is alive through the LFU visit. No other factors are considered in the evaluation of survival.
Interventions
- DRUG Amikacin Inhalation Solution (BAY41-6551)
- DRUG Aerosolized Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 725 participants |
| Start Date | 2013-04-13 |
| Est. Completion | 2017-04-07 |
| Phase | Phase 3 |
What the finished NCT01799993 record still lists
NCT01799993 is an interventional study that assigns participants to a tested intervention. The registered 725 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Amikacin Inhalation Solution (BAY41-6551) is the first listed.
NCT01799993 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01799993 about?
NCT01799993 is a clinical study titled "Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia". To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System (PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal saline) administered as an...
What is the current status of trial NCT01799993?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 725 participants. The study started on 2013-04-13. Estimated completion is 2017-04-07.
What interventions are being tested in trial NCT01799993?
The interventions under investigation include: Amikacin Inhalation Solution (BAY41-6551) (DRUG), Aerosolized Placebo (DRUG).
Who is sponsoring clinical trial NCT01799993?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01799993's enrollment target sits among peer trials
725 491st of 2000 higher than 1,510 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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