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)
NCT ID: NCT01004445
Last Updated: 2011-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
69 participants
INTERVENTIONAL
2005-05-31
2006-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1
Amikacin (BAY41-6551)
Single daily dose of 400 mg aerosolized amikacin and a single dose of aerosolized placebo on a rotating every 12hr schedule
Arm 2
Amikacin (BAY41-6551)
Daily dose of 800 mg aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment every 12hr
Arm 3
Placebo
Two aerosol treatments per day (one treatment every 12hr)
Interventions
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Amikacin (BAY41-6551)
Single daily dose of 400 mg aerosolized amikacin and a single dose of aerosolized placebo on a rotating every 12hr schedule
Amikacin (BAY41-6551)
Daily dose of 800 mg aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment every 12hr
Placebo
Two aerosol treatments per day (one treatment every 12hr)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Nektar Therapeutics
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Bayer Healthcare AG
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
Melbourne, Florida, United States
Albany, New York, United States
Winston-Salem, North Carolina, United States
Columbus, Ohio, United States
Houston, Texas, United States
San Antonio, Texas, United States
Angers, , France
Limoges, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Rouen, , France
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Murcia, , Spain
Countries
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References
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Niederman MS, Chastre J, Corkery K, Fink JB, Luyt CE, Garcia MS. BAY41-6551 achieves bactericidal tracheal aspirate amikacin concentrations in mechanically ventilated patients with Gram-negative pneumonia. Intensive Care Med. 2012 Feb;38(2):263-71. doi: 10.1007/s00134-011-2420-0. Epub 2011 Dec 7.
Other Identifiers
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AMIK-04-02
Identifier Type: -
Identifier Source: org_study_id
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