Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 725 participants.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01799993
The ClinicalTrials.gov registry entry for NCT01799993 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 725 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Amikacin Inhalation Solution (BAY41-6551) is the first listed.
NCT01799993 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.