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)

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT01004445

Collaborator

Nektar Therapeutics (Industry)

Enrollment

Locations

Arms

Duration (Months)

3.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pneumonia	Drug: Amikacin (BAY41-6551) Drug: Amikacin (BAY41-6551) Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

69 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2005

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Jun 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Amikacin (BAY41-6551) Single daily dose of 400 mg aerosolized amikacin and a single dose of aerosolized placebo on a rotating every 12hr schedule
Experimental: Arm 2	Drug: Amikacin (BAY41-6551) Daily dose of 800 mg aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment every 12hr
Placebo Comparator: Arm 3	Drug: Placebo Two aerosol treatments per day (one treatment every 12hr)

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Amikacin (BAY41-6551)

Single daily dose of 400 mg aerosolized amikacin and a single dose of aerosolized placebo on a rotating every 12hr schedule

Experimental: Arm 2

Drug: Amikacin (BAY41-6551)

Daily dose of 800 mg aerosolized amikacin delivered in two divided doses of 400 mg per aerosol treatment every 12hr

Placebo Comparator: Arm 3

Drug: Placebo

Two aerosol treatments per day (one treatment every 12hr)

Outcome Measures

Primary Outcome Measures

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 [Day 1]

Secondary Outcome Measures

Mean C(max) and mean AUC of amikacin in tracheal aspirates [Day 1 and Day 3 of treatment period]
Mean ratio of C (max) / MIC and mean ratio of AUC (0-24 hr) / MIC [Day 1 and Day 3 of treatment period]
Clinical cure rate [Test of cure visit (7 days post last treatment dose)]
Microbiological eradication rate of identified pathogens [Test of cure visit (7 days post last treatment dose)]
Microbiological persistence rate [Test of cure visit (7 days post last treatment dose)]
New infection rate [Test of cure visit (7 days post last treatment dose)]
Assessment of adverse events related to drug or device [Treatment period, early post treatment period, test of cure visit, and late post treatment]
Assessment of abnormal laboratory values [Treatment period, early post treatment period, test of cure visit, and late post treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Birmingham	Alabama	United States	35233
2	Melbourne	Florida	United States	32901
3	Albany	New York	United States	12208
4	Winston-Salem	North Carolina	United States	27157
5	Columbus	Ohio	United States	43210
6	Houston	Texas	United States	77030
7	San Antonio	Texas	United States	78229
8	Angers Cedex 9		France	49933
9	Limoges Cedex		France	87046
10	Paris Cedex 13		France	75651
11	Paris Cedex 14		France	75674
12	Paris Cedex 15		France	75908
13	Paris		France	75018
14	Rouen cedex		France	76031
15	Barcelona		Spain	08003
16	Barcelona		Spain	08036
17	Madrid		Spain	28034
18	Madrid		Spain	28040
19	Madrid		Spain	28805
20	Murcia		Spain	30120