Back to resultsA 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)
Primary Purpose
Pneumonia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Amikacin (BAY41-6551)
Amikacin (BAY41-6551)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia focused on measuring Pneumonia, Adjunctive treatment, Gram-negative bacteria
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with compromised of suppressed immune systems, severe hypoxemia, PEEP>15cm H2O, creatinine>2 mg/dL, or who are pregnant
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Mean C(max) and mean AUC of amikacin in tracheal aspirates
Mean ratio of C (max) / MIC and mean ratio of AUC (0-24 hr) / MIC
Clinical cure rate
Microbiological eradication rate of identified pathogens
Microbiological persistence rate
New infection rate
Assessment of adverse events related to drug or device
Assessment of abnormal laboratory values
Full Information
NCT ID
NCT01004445
First Posted
October 29, 2009
Last Updated
April 7, 2011
Sponsor
Bayer
Collaborators
Nektar Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT01004445
Brief Title
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)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bayer
Collaborators
Nektar Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
Pneumonia, Adjunctive treatment, Gram-negative bacteria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Amikacin (BAY41-6551)
Intervention Description
Single daily dose of 400 mg aerosolized amikacin and a single dose of aerosolized placebo on a rotating every 12hr schedule
Intervention Type
Drug
Intervention Name(s)
Amikacin (BAY41-6551)
Intervention Description
Daily dose of 800 mg aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment every 12hr
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two aerosol treatments per day (one treatment every 12hr)
Primary Outcome Measure Information:
Title
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
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Mean C(max) and mean AUC of amikacin in tracheal aspirates
Time Frame
Day 1 and Day 3 of treatment period
Title
Mean ratio of C (max) / MIC and mean ratio of AUC (0-24 hr) / MIC
Time Frame
Day 1 and Day 3 of treatment period
Title
Clinical cure rate
Time Frame
Test of cure visit (7 days post last treatment dose)
Title
Microbiological eradication rate of identified pathogens
Time Frame
Test of cure visit (7 days post last treatment dose)
Title
Microbiological persistence rate
Time Frame
Test of cure visit (7 days post last treatment dose)
Title
New infection rate
Time Frame
Test of cure visit (7 days post last treatment dose)
Title
Assessment of adverse events related to drug or device
Time Frame
Treatment period, early post treatment period, test of cure visit, and late post treatment
Title
Assessment of abnormal laboratory values
Time Frame
Treatment period, early post treatment period, test of cure visit, and late post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patients with compromised of suppressed immune systems, severe hypoxemia, PEEP>15cm H2O, creatinine>2 mg/dL, or who are pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Angers Cedex 9
ZIP/Postal Code
49933
Country
France
City
Limoges Cedex
ZIP/Postal Code
87046
Country
France
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
City
Paris Cedex 14
ZIP/Postal Code
75674
Country
France
City
Paris Cedex 15
ZIP/Postal Code
75908
Country
France
City
Paris
ZIP/Postal Code
75018
Country
France
City
Rouen cedex
ZIP/Postal Code
76031
Country
France
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Madrid
ZIP/Postal Code
28805
Country
Spain
City
Murcia
ZIP/Postal Code
30120
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
22147112
Citation
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.
Results Reference
derived
Learn more about this trial
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)
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