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

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
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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
Status
LocationsStatus
Locations

Investigative Site

San Antonio, United States, 78229

Status
Completed
 
Locations

Investigative Site

Houston, United States, 77030

Status
Completed
 
Locations

Investigative Site

Winston-Salem, United States, 27157

Status
Completed
 
Locations

Investigative Site

Birmingham, United States, 35233

Status
Completed
 
Locations

Investigative Site

Columbus, United States, 43210

Status
Completed
 
Locations

Investigative Site

Melbourne, United States, 32901

Status
Completed
 
Locations

Investigative Site

Albany, United States, 12208

Status
Completed
 
Locations

Investigative Site

Paris Cedex 14, France, 75674

Status
Completed
 
Locations

Investigative Site

Paris Cedex 13, France, 75651

Status
Completed
 
Locations

Investigative Site

Limoges Cedex, France, 87046

Status
Completed
 
Locations

Investigative Site

Paris Cedex 15, France, 75908

Status
Completed
 
Locations

Investigative Site

Angers Cedex 9, France, 49933

Status
Completed
 
Locations

Investigative Site

Rouen cedex, France, 76031

Status
Completed
 
Locations

Investigative Site

Paris, France, 75018

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28805

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08003

Status
Completed
 
Locations

Investigative Site

Murcia, Spain, 30120

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28034

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28040

Status
Completed
 

Trial Design