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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01004445
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : April 8, 2011
Nektar Therapeutics
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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).

Condition or disease Intervention/treatment Phase
Pneumonia Drug: Amikacin (BAY41-6551) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Arm 1 Drug: Amikacin (BAY41-6551)
Single daily dose of 400 mg aerosolized amikacin and a single dose of aerosolized placebo on a rotating every 12hr schedule

Experimental: Arm 2 Drug: Amikacin (BAY41-6551)
Daily dose of 800 mg aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment every 12hr

Placebo Comparator: Arm 3 Drug: Placebo
Two aerosol treatments per day (one treatment every 12hr)

Primary Outcome Measures :
  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 [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Mean C(max) and mean AUC of amikacin in tracheal aspirates [ Time Frame: Day 1 and Day 3 of treatment period ]
  2. 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 ]
  3. Clinical cure rate [ Time Frame: Test of cure visit (7 days post last treatment dose) ]
  4. Microbiological eradication rate of identified pathogens [ Time Frame: Test of cure visit (7 days post last treatment dose) ]
  5. Microbiological persistence rate [ Time Frame: Test of cure visit (7 days post last treatment dose) ]
  6. New infection rate [ Time Frame: Test of cure visit (7 days post last treatment dose) ]
  7. 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 ]
  8. Assessment of abnormal laboratory values [ Time Frame: Treatment period, early post treatment period, test of cure visit, and late post treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01004445

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United States, Alabama
Birmingham, Alabama, United States, 35233
United States, Florida
Melbourne, Florida, United States, 32901
United States, New York
Albany, New York, United States, 12208
United States, North Carolina
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Texas
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
Angers Cedex 9, France, 49933
Limoges Cedex, France, 87046
Paris Cedex 13, France, 75651
Paris Cedex 14, France, 75674
Paris Cedex 15, France, 75908
Paris, France, 75018
Rouen cedex, France, 76031
Barcelona, Spain, 08003
Barcelona, Spain, 08036
Madrid, Spain, 28034
Madrid, Spain, 28040
Madrid, Spain, 28805
Murcia, Spain, 30120
Sponsors and Collaborators
Nektar Therapeutics
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Study Director: Bayer Study Director Bayer

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Head Clinical Pharmacology, Bayer Healthcare AG Identifier: NCT01004445     History of Changes
Other Study ID Numbers: AMIK-04-02
First Posted: October 30, 2009    Key Record Dates
Last Update Posted: April 8, 2011
Last Verified: April 2011

Keywords provided by Bayer:
Adjunctive treatment
Gram-negative bacteria

Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Anti-Infective Agents