Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia

PHASE3CompletedINTERVENTIONAL
Enrollment

725

Participants

Timeline

Start Date

April 13, 2013

Primary Completion Date

April 7, 2017

Study Completion Date

April 7, 2017

Conditions
Pneumonia, Bacterial
Interventions
DRUG

Amikacin Inhalation Solution (BAY41-6551)

400 mg of aerosolized amikacin every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)

DRUG

Aerosolized Placebo

Aerosolized placebo every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)

Trial Locations (65)

710

Tainan City

1105

Quezon City

2148

Blacktown

2500

Wollongong

3168

Clayton

10019

New York

10065

Mineola

New York

11215

Brooklyn

11217

Taipei

19713

Newark

20000

Aguascalientes

27401

Greensboro

28801

Asheville

29425

Charleston

30342

Atlanta

33125

Miami

35233

Birmingham

36617

Mobile

40002

Khon Kaen

41701

Hazard

43215

Columbus

44195

Cleveland

44340

Guadalajara

44501

Youngstown

47303

Muncie

49007

Kalamazoo

50200

Chiang Mai

52242

Iowa City

59701

Butte

61080

Trabzon

62702

Springfield

64460

Monterrey

65803

Springfield

73117

Oklahoma City

78240

San Luis Potosí City

82445

Kaohsiung City

89109

Las Vegas

13060904

Campinas

85008-4956

Phoenix

06810

Danbury

06102

Hartford

33021-5421

Hollywood

33606-3508

Tampa

63110-1093

St Louis

45267-0769

Cincinnati

44109-1998

Cleveland

30150 221

Belo Horizonte

Unknown

São José do Rio Preto

Kingston

Barranquilla

Santiago de Cali

Taipei

K1H 8L6

Ottawa

M5T 2S8

Toronto

H1T 2M4

Montreal

G1V 4G5

Québec

100 34

Prague

762 75

Zlín

07760

México, D.F.

NCR 1100

Quezon City

136-705

Seoul

137-701

Seoul

138-736

Seoul

06100

Ankara

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Nektar Therapeutics

INDUSTRY

lead

Bayer

INDUSTRY

NCT01799993 - Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia | Biotech Hunter | Biotech Hunter