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)

PHASE2CompletedINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

June 30, 2006

Study Completion Date

June 30, 2006

Conditions
Pneumonia
Interventions
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

DRUG

Amikacin (BAY41-6551)

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

DRUG

Placebo

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

Trial Locations (20)

12208

Albany

27157

Winston-Salem

28034

Madrid

28040

Madrid

28805

Madrid

30120

Murcia

32901

Melbourne

35233

Birmingham

43210

Columbus

49933

Angers

75018

Paris

75651

Paris

75674

Paris

75908

Paris

76031

Rouen

77030

Houston

78229

San Antonio

87046

Limoges

08003

Barcelona

08036

Barcelona

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Nektar Therapeutics

INDUSTRY

lead

Bayer

INDUSTRY