Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia

PHASE2CompletedINTERVENTIONAL
Enrollment

143

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

March 31, 2016

Study Completion Date

April 30, 2016

Conditions
Pneumonia, Bacterial
Interventions
DRUG

Amikacin fosfomycin inhalation solution

300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System

DRUG

Aerosolized placebo

Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System

Trial Locations (41)

1081

Budapest

1125

Budapest

4012

Debrecen

4043

Debrecen

10676

Athens

11527

Athens

12462

Athens

15227

Athens

21686

Lexington

28905

Getafe

32209

Jacksonville

32610

Gainesville

34098

Istanbul

34760

Istanbul

37044

Tours

37920

Knoxville

41334

Larissa

41701

Hazard

45000

Orléans

45500

Ioannina

48202

Detroit

54500

Vandœuvre-lès-Nancy

60198

Omaha

60612

Chicago

61080

Trabzon

63110

St Louis

68100

Alexandroupoli

73104

Oklahoma City

77030

Houston

79905

El Paso

87042

Limoges

90033

Los Angeles

92701

Colombes

02119

Boston

01805

Burlington

01199

Springfield

00921

San Juan

07010

Palma de Majorca

08036

Barcelona

06100

Ankara

06110

Ankara

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cardeas Pharma

INDUSTRY