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