DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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)

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia

Intervention: Amikacin (BAY41-6551) (Drug); Amikacin (BAY41-6551) (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer


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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: 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:

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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Angers Cedex 9 49933, France

Limoges Cedex 87046, France

Paris Cedex 13 75651, France

Paris Cedex 14 75674, France

Paris Cedex 15 75908, France

Paris 75018, France

Rouen cedex 76031, France

Barcelona 08003, Spain

Barcelona 08036, Spain

Madrid 28034, Spain

Madrid 28040, Spain

Madrid 28805, Spain

Murcia 30120, Spain

Birmingham, Alabama 35233, United States

Melbourne, Florida 32901, United States

Albany, New York 12208, United States

Winston-Salem, North Carolina 27157, United States

Columbus, Ohio 43210, United States

Houston, Texas 77030, United States

San Antonio, Texas 78229, United States

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: May 2005
Last updated: April 7, 2011

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017