Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
Public ClinicalTrials.gov record NCT01799993. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients With Gram-Negative Pneumonia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01799993
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 725 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 12, 2013
- Primary completion
- Apr 6, 2017
- Completion
- Apr 6, 2017
- Last update posted
- Jul 22, 2018
2013 – 2017
United States locations
- U.S. sites
- 32
- U.S. states
- 19
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35233 | — |
| Not listed | Mobile | Alabama | 36617 | — |
| Not listed | Phoenix | Arizona | 85008-4956 | — |
| Not listed | Danbury | Connecticut | 06810 | — |
| Not listed | Hartford | Connecticut | 06102 | — |
| Not listed | Newark | Delaware | 19713 | — |
| Not listed | Hollywood | Florida | 33021-5421 | — |
| Not listed | Miami | Florida | 33125 | — |
| Not listed | Tampa | Florida | 33606-3508 | — |
| Not listed | Atlanta | Georgia | 30342 | — |
| Not listed | Springfield | Illinois | 62702 | — |
| Not listed | Muncie | Indiana | 47303 | — |
| Not listed | Iowa City | Iowa | 52242 | — |
| Not listed | Hazard | Kentucky | 41701 | — |
| Not listed | Kalamazoo | Michigan | 49007 | — |
| Not listed | Springfield | Missouri | 65803 | — |
| Not listed | St Louis | Missouri | 63110-1093 | — |
| Not listed | Butte | Montana | 59701 | — |
| Not listed | Las Vegas | Nevada | 89109 | — |
| Not listed | Brooklyn | New York | 11215 | — |
| Not listed | Mineola | New York | 10065 | — |
| Not listed | New York | New York | 10019 | — |
| Not listed | New York | New York | 10065 | — |
| Not listed | Asheville | North Carolina | 28801 | — |
| Not listed | Greensboro | North Carolina | 27401 | — |
| Not listed | Cincinnati | Ohio | 45267-0769 | — |
| Not listed | Cleveland | Ohio | 44109-1998 | — |
| Not listed | Cleveland | Ohio | 44195 | — |
| Not listed | Columbus | Ohio | 43215 | — |
| Not listed | Youngstown | Ohio | 44501 | — |
| Not listed | Oklahoma City | Oklahoma | 73117 | — |
| Not listed | Charleston | South Carolina | 29425 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 33 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01799993, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 22, 2018 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01799993 live on ClinicalTrials.gov.