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)
A Double-Blind, Placebo-controlled Parallel Group, Phase II Dose-Ranging Study of Nebulized Amikacin Delivered Via the Pulmonary Drug Delivery System (PDDS) in Ventilated Patients With Nosocomial Pneumonia Due to Gram Negative Organisms
1 other identifier
interventional
69
3 countries
20
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2005
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 29, 2009
CompletedFirst Posted
Study publicly available on registry
October 30, 2009
CompletedApril 8, 2011
April 1, 2011
1.1 years
October 29, 2009
April 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients who achieve a C(max) for amikacin in tracheal aspirates at least 25 times greater than the reference MIC for hospital-acquired organisms and an AUC (0-24 hr) / MIC ratio that is 100 or greater on Day 1
Day 1
Secondary Outcomes (8)
Mean C(max) and mean AUC of amikacin in tracheal aspirates
Day 1 and Day 3 of treatment period
Mean ratio of C (max) / MIC and mean ratio of AUC (0-24 hr) / MIC
Day 1 and Day 3 of treatment period
Clinical cure rate
Test of cure visit (7 days post last treatment dose)
Microbiological eradication rate of identified pathogens
Test of cure visit (7 days post last treatment dose)
Microbiological persistence rate
Test of cure visit (7 days post last treatment dose)
- +3 more secondary outcomes
Study Arms (3)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALArm 3
PLACEBO COMPARATORInterventions
Single daily dose of 400 mg aerosolized amikacin and a single dose of aerosolized placebo on a rotating every 12hr schedule
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Nektar Therapeuticscollaborator
Study Sites (20)
Unknown Facility
Birmingham, Alabama, 35233, United States
Unknown Facility
Melbourne, Florida, 32901, United States
Unknown Facility
Albany, New York, 12208, United States
Unknown Facility
Winston-Salem, North Carolina, 27157, United States
Unknown Facility
Columbus, Ohio, 43210, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Angers, 49933, France
Unknown Facility
Limoges, 87046, France
Unknown Facility
Paris, 75018, France
Unknown Facility
Paris, 75651, France
Unknown Facility
Paris, 75674, France
Unknown Facility
Paris, 75908, France
Unknown Facility
Rouen, 76031, France
Unknown Facility
Barcelona, 08003, Spain
Unknown Facility
Barcelona, 08036, Spain
Unknown Facility
Madrid, 28034, Spain
Unknown Facility
Madrid, 28040, Spain
Unknown Facility
Madrid, 28805, Spain
Unknown Facility
Murcia, 30120, Spain
Related Publications (1)
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.
PMID: 22147112DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 29, 2009
First Posted
October 30, 2009
Study Start
May 1, 2005
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
April 8, 2011
Record last verified: 2011-04