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)

Bayer69 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pneumonia

Interventions

Amikacin (BAY41-6551)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (20)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Melbourne, Florida, United States

Unnamed facility

Albany, New York, United States

Unnamed facility

Winston-Salem, North Carolina, United States

Unnamed facility

Columbus, Ohio, United States

Unnamed facility

Houston, Texas, United States

Unnamed facility

San Antonio, Texas, United States

Unnamed facility

Angers, France

Unnamed facility

Limoges, France

Unnamed facility

Paris, France

...and 10 more locations

Outcomes

Primary Outcomes

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 Outcomes

Mean C(max) and mean AUC of amikacin in tracheal aspirates

Time frame: Day 1 and Day 3 of treatment period

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

Clinical cure rate

Time frame: Test of cure visit (7 days post last treatment dose)

Microbiological eradication rate of identified pathogens

Time frame: Test of cure visit (7 days post last treatment dose)

Microbiological persistence rate

Time frame: Test of cure visit (7 days post last treatment dose)

New infection rate

Time frame: Test of cure visit (7 days post last treatment dose)

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

Assessment of abnormal laboratory values

Time frame: Treatment period, early post treatment period, test of cure visit, and late post treatment