Clinical trial NCT01004445: 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)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumonia
Keywords: Pneumonia
Adjunctive treatment
Gram-negative bacteria
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Nektar Therapeutics
First posted: 2009-10-30
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Day 1
Secondary outcomes:
measure: Mean C(max) and mean AUC of amikacin in tracheal aspirates
timeFrame: Day 1 and Day 3 of treatment period
measure: Mean ratio of C (max) / MIC and mean ratio of AUC (0-24 hr) / MIC
timeFrame: Day 1 and Day 3 of treatment period
measure: Clinical cure rate
timeFrame: Test of cure visit (7 days post last treatment dose)
measure: Microbiological eradication rate of identified pathogens
timeFrame: Test of cure visit (7 days post last treatment dose)
measure: Microbiological persistence rate
timeFrame: Test of cure visit (7 days post last treatment dose)
measure: New infection rate
timeFrame: Test of cure visit (7 days post last treatment dose)
measure: Assessment of adverse events related to drug or device
timeFrame: Treatment period, early post treatment period, test of cure visit, and late post treatment
measure: Assessment of abnormal laboratory values
timeFrame: Treatment period, early post treatment period, test of cure visit, and late post treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Melbourne
country: United States
state: Florida
city: Albany
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Angers Cedex 9
country: France
city: Limoges Cedex
country: France
city: Paris Cedex 13
country: France
city: Paris Cedex 14
country: France
city: Paris Cedex 15
country: France
city: Paris
country: France
city: Rouen cedex
country: France
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Murcia
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Niederman MS, Chastre J, Corkery K, Fink JB, Luyt CE, Garcia MS. BAY41-6551 achieves bactericidal tracheal aspirate amikacin concentrations in mechanically ventilated patients with Gram-negative pneumonia. Intensive Care Med. 2012 Feb;38(2):263-71. doi: 10.1007/s00134-011-2420-0. Epub 2011 Dec 7.