A Study to Determine the Correct Dose of Amikacin Which is Delivered Directly to the Lungs of Ventilated Patients as an Aerosol Via an Investigational Device Called the Pulmonary Delivery Device System (PDDS)

2014-08-27 03:18:20 | BioPortfolio


This study is part of a research program too see if amikacin delivered as an aerosol directly to the lungs in combination with IV antibiotic therapy can help intubated patients with gram-negative pneumonia get better faster than when given intravenous antibiotics alone. The primary purpose of this study is to determine the correct dose of amikacin which is delivered directly to the lungs as an aerosol via an investigational device called the Pulmonary Delivery Device System (PDDS).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment




Amikacin (BAY41-6551), Amikacin (BAY41-6551), Placebo


United States





Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:18:20-0400

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Medical and Biotech [MESH] Definitions

A broad-spectrum antibiotic derived from KANAMYCIN. It is reno- and oto-toxic like the other aminoglycoside antibiotics.

Pneumonia caused by infection with bacteria of the family RICKETTSIACEAE.

Pneumonia due to aspiration or inhalation of various oily or fatty substances.

Severe complication of pneumonia characterized by liquefaction of lung tissue.

A species of the genus PNEUMOVIRUS causing pneumonia in mice.

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