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)

Completed · Phase 2 · Has a placebo group

Conditions studied: Pneumonia

In brief

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).

Key facts

Study ID

NCT01004445

Run by

Bayer

People needed

69

Starts

2005-05-01

Expected to finish

2006-06-01

Last updated by the study team

2011-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients 18 years of age or older with a clinical diagnosis of VAP, HAP or HCAP who are expected to be on mechanical ventilation for at least 3 days

You may not qualify if…

• Patients with compromised of suppressed immune systems, severe hypoxemia, PEEP>15cm H2O, creatinine>2 mg/dL, or who are pregnant

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Melbourne, Florida, United States
• Study site — Albany, New York, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Columbus, Ohio, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Angers, France
• Study site — Limoges, France
• Study site — Paris, France
• Study site — Paris, France
• Study site — Paris, France
• Study site — Paris, France
• Study site — Rouen, France
• Study site — Barcelona, Spain
• Study site — Barcelona, Spain
• Study site — Madrid, Spain
• Study site — Madrid, Spain
• Study site — Madrid, Spain
• Study site — Murcia, Spain

Full record on ClinicalTrials.gov

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