Trial Condition(s):

Pneumonia

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)

Bayer Identifier:

AMIK-04-02

ClinicalTrials.gov Identifier:

NCT01004445

EudraCT Number:

2005-000060-16

EU CT Number:

Not Available

Study Completed

Trial Purpose

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).

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

Trial Summary

Enrollment Goal
69
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Amikacin Inhalation Solution (BAY41-6551)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Investigative Site

San Antonio, United States, 78229

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Investigative Site

Houston, United States, 77030

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Investigative Site

Winston-Salem, United States, 27157

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Birmingham, United States, 35233

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Columbus, United States, 43210

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Melbourne, United States, 32901

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Investigative Site

Albany, United States, 12208

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Investigative Site

Paris Cedex 14, France, 75674

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Paris Cedex 13, France, 75651

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Investigative Site

Limoges Cedex, France, 87046

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Investigative Site

Paris Cedex 15, France, 75908

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Angers Cedex 9, France, 49933

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Rouen cedex, France, 76031

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Investigative Site

Paris, France, 75018

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Investigative Site

Madrid, Spain, 28805

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Investigative Site

Barcelona, Spain, 08036

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Barcelona, Spain, 08003

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Investigative Site

Murcia, Spain, 30120

Locations

Investigative Site

Madrid, Spain, 28034

Locations

Investigative Site

Madrid, Spain, 28040

Trial Design