Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia

ClinicalTrials.gov ID: NCT01799993

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.

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ClinicalTrials.gov public records Last synced Oct 21, 2026, 6:52 AM EDT

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
Lead sponsor: Bayer; Industry
Enrollment: 725 participants

Conditions and interventions

Conditions

Pneumonia, Bacterial

Interventions

Amikacin Inhalation Solution (BAY41-6551) Drug
Aerosolized Placebo Drug

Drug

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 13, 2013 (Actual)
Primary completion: Apr 7, 2017 (Actual)
Completion: Apr 7, 2017 (Actual)
Last update posted: Jul 23, 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 23, 2018 · Synced Oct 21, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01799993 live on ClinicalTrials.gov.

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