Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens

PHASE3CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

October 24, 2017

Primary Completion Date

February 26, 2019

Study Completion Date

April 1, 2019

Conditions
Healthcare-associated Pneumonia (HCAP)Hospital Acquired Pneumonia (HAP)Ventilator Associated Pneumonia (VAP)
Interventions
DRUG

Cefiderocol

2000 mg intravenously every 8 hours for a period of 7 to14 days (dosage adjustment is necessary based on renal function)

DRUG

Meropenem

2000 mg intravenously every 8 hours for a period of 7 to 14 days (dosage adjustment is necessary based on renal function)

DRUG

Linezolid

600 mg of linezolid administered intravenously over 30 minutes to 2 hours, every 12 hours.

Trial Locations (119)

235

Shionogi Research Site, New Taipei City

1000

Shionogi Research Site, Manila

1012

Shionogi Research Site, Tondo

1020

Shionogi Research Site, Brussels

1070

Shionogi Research Site, Brussels

1104

Shionogi Research Site, Quezon City

1109

Shionogi Research Site, Quezon City

1121

Shionogi Research Site, Budapest

1125

Shionogi Research Site, Budapest

1400

Shionogi Research Site, Caloocan City

1427

Shionogi Research Site, Caloocan City

4600

Shionogi Research Site, Kutaisi

4601

Shionogi Research Site, Kutaisi

4900

Shionogi Research Site, Fehérgyarmat

5000

Shionogi Research Site, Jaro

Shionogi Research Site, Iloilo City

6010

Shionogi Research Site, Batumi

8000

Shionogi Research Site, Székesfehérvár

8036

Shionogi Research Site, Barcelona

10002

Shionogi Research Site, Taipei

11000

Shionogi Research Site, Belgrade

11696

Shionogi Research Site, Taipei

13419

Shionogi Research Site, Tallinn

15006

Shionogi Research Site, Prague

18105

Shionogi Research Site, Bethlehem

19141

Shionogi Research Site, Philadelphia

20246

Shionogi Research Site, Hamburg

21029

Shionogi Research Site, Vinnitsya

21204

Shionogi Research Site, Kamenitz

21404

Shionogi Research Site, Annapolis

26101

Shionogi Research Site, Příbram

28000

Shionogi Research Site, Kolín

28007

Shionogi Research Site, Madrid

28850

Shionogi Research Site, Torrejón de Ardoz

28922

Shionogi Research Site, Madrid

31025

Shionogi Research Site, Kohtla-Järve

32720

Shionogi Research Site, DeLand

34000

Shionogi Research Site, Kragujevac

36038

Shionogi Research Site, Poltava

39617

Shionogi Research Site, Kremenchuk

40031

Shionogi Research Site, Sumy

40202

Shionogi Research Site, Louisville

40705

Shionogi Research Site, Taichung

44106

Shionogi Research Site, Cleveland

46010

Shionogi Research Site, Valencia

48201

Shionogi Research Site, Detroit

49000

Shionogi Research Site, Dnipropetrovsk

49100

Shionogi Research Site, Tikva

49933

Shionogi Research Site, Angers

50005

Shionogi Research Site, Hradec Králové

51014

Shionogi Research Site, Tartu

51503

Shionogi Research Site, Council Bluffs

52621

Shionogi Research Site, Tel Litwinsky

53127

Shionogi Research Site, Bonn

58001

Shionogi Research Site, Chernivtsi

58100

Shionogi Research Site, Holon

60612

Shionogi Research Site, Chicago

61037

Shionogi Research Site, Kharkiv

61103

Shionogi Research Site, Kharkiv

64239

Shionogi Research Site, Tel Aviv

65693

Shionogi Research Site, Brno

69035

Shionogi Research Site, Zaporizhzhya

69120

Shionogi Research Site, Heidelberg

69437

Shionogi Research Site, Lyon

69677

Shionogi Research Site, Bron

69701

Shionogi Research Site, Kyjov

70808

Shionogi Research Site, Baton Rouge

71103

Shionogi Research Site, Shreveport

73000

Shionogi Research Site, Kherson

75018

Shionogi Research Site, Paris

76008

Shionogi Research Site, Ivano-Frankivsk

80010

Shionogi Research Site, Pärnu

84132

Shionogi Research Site, Salt Lake City

85925

Shionogi Research Site, LaRoche-sur-Yon

95100

Shionogi Research Site, Argenteuil

105203

Shionogi Research Site, Moscow

115280

Shionogi Research Site, Moscow

127015

Shionogi Research Site, Moscow

192242

Shionogi Research Site, Saint Petersburg

194354

Shionogi Research Site, Sait-Petersburg

196247

Shionogi Research Site, Saint Petersburg

197706

Shionogi Research Site, Saint Petersburg

214019

Shionogi Research Site, Smolensk

350012

Shionogi Research Site, Krasnodar

454000

Shionogi Research Site, Chelyabinsk

454091

Shionogi Research Site, Saint Petersburg

630051

Shionogi Research Site, Novosibirsk

630075

Shionogi Research Site, Novosibirsk

634063

Shionogi Research Site, Tomsk

656024

Shionogi Research Site, Barnaul

656045

Shionogi Research Site, Barnaul

9103102

Shionogi Research Site, Jerusalem

06511

Shionogi Research Site, New Haven

63110-0250

Shionogi Research Site, St Louis

43210-1267

Shionogi Research Site, Columbus

B3H3A7

Shionogi Research Site, Halifax

K7L 2V7

Shionogi Research Site, Kingston

708 52

Shionogi Research Site, Ostrava-Poruba

06202

Shionogi Research Site, Nice

0160

Shionogi Research Site, Tbilisi

04103

Shionogi Research Site, Leipzig

H-4031

Shionogi Research Site, Debrecen

371-8511

Shionogi Research Site, Maebashi

300-8585

Shionogi Research Site, Tsuchiura

514-8507

Shionogi Research Site, Tsu

901-1193

Shionogi Research Site, Shimajiri-gun

173-8610

Shionogi Research Site, Itabashi-ku

860-0008

Shionogi Research Site, Kumamoto

LV-5417

Shionogi Research Site, Daugavpils

LV-3414

Shionogi Research Site, Liepāja

LV-1006

Shionogi Research Site, Riga

LV-1002

Shionogi Research Site, Saldus Novads

00921

Shionogi Research Site, San Juan

03010

Shionogi Research Site, Alicante

08003

Shionogi Research Site, Barcelona

08026

Shionogi Research Site, Barcelona

03186

Shionogi Research Site, Torrevieja

01133

Shionogi Research Site, Kiev

041112

Shionogi Research Site, Kiev

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shionogi

INDUSTRY