Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens

PHASE3CompletedINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

September 7, 2016

Primary Completion Date

April 1, 2019

Study Completion Date

April 22, 2019

Conditions
Healthcare-associated Pneumonia (HCAP)Bloodstream Infections (BSI)Hospital Acquired Pneumonia (HAP)Complicated Urinary Tract Infection (cUTI)SepsisVentilator Associated Pneumonia (VAP)
Interventions
DRUG

Cefiderocol

2 g intravenously over 3 hours every 8 hours for a period of 7 to 14 days, or 2 g every 6 hours for participants with creatinine clearance \>120 mL/min.

DRUG

Best Available Therapy

Standard of care with either a polymyxin-based or non-polymyxin-based regimen as determined by the investigator and consisting of one to three marketed antibacterial agent(s).

Trial Locations (85)

5030

Shionogi Research Site, Seoul

10000

Shionogi Research Site, Zagreb

10002

Shionogi Research Site, Taipei City

10700

Shionogi Research Site, Bangkok

11000

Shionogi Research Site, Muang Nonthaburi

11526

Shionogi Research Site, Athens

12351

Shionogi Research Site, Berlin

12462

Shionogi Research Site, Athens

13005

Shionogi Research Site, Ciudad Real

13100

Shionogi Research Site, Safed

14004

Shionogi Research Site, Córdoba

15090

Shionogi Research Site, São José do Rio Preto

15213

Shionogi Research Site, Pittsburgh

17007

Shionogi Research Site, Girona

19718

Shionogi Research Site, Newark

20122

Shionogi Research Site, Milan

20132

Shionogi Research Site, Milan

20162

Shionogi Research Site, Milan

21000

Shionogi Research Site, Split

25198

Shionogi Research Site, Lleida

26426

Shionogi Research Site, Wŏnju

26504

Shionogi Research Site, Patra

28046

Shionogi Research Site, Madrid

29010

Shionogi Research Site, Málaga

31048

Shionogi Research Site, Haifa

33100

Shionogi Research Site, Udine

34098

Shionogi Research Site, Istanbul

34214

Shionogi Research Site, Istanbul

35100

Shionogi Research Site, Bornova

38043

Shionogi Research Site, La Tronche

38100

Shionogi Research Site, Hadera

40002

Shionogi Research Site, Muang

40447

Shionogi Research Site, Taichung

40705

Shionogi Research Site, Taichung

41009

Shionogi Research Site, Seville

41110

Shionogi Research Site, Larissa

41124

Shionogi Research Site, Modena

41221

Shionogi Research Site, Larissa

41931

Shionogi Research Site, Daegu

41944

Shionogi Research Site, Daegu

46015

Shionogi Research Site, Valencia

48202

Shionogi Research Site, Detroit

50009

Shionogi Research Site, Zaragoza

51000

Shionogi Research Site, Rijeka

52621

Shionogi Research Site, Tel Litwinsky

53105

Shionogi Research Site, Bonn

56124

Shionogi Research Site, Cisanello

58100

Shionogi Research Site, Holon

60611

Shionogi Research Site, Chicago

64239

Shionogi Research Site, Tel Aviv

69120

Shionogi Research Site, Heidelberg

70121

Shionogi Research Site, New Orleans

70300

Shionogi Research Site, Be’er Ya‘aqov

75018

Shionogi Research Site, Paris

80050

Shionogi Research Site, Curitiba

81362

Shionogi Research Site, Kaohsiung City

84101

Shionogi Research Site, Beersheba

91120

Shionogi Research Site, Jerusalem

97002

Shionogi Research Site, Hualien City

3109601

Shionogi Research Site, Haifa

06102

Shionogi Research Site, Hartford

41810-011

Shionogi Research Site, Salvador

99010-080

Shionogi Research Site, Passo Fundo

90035-074

Shionogi Research Site, Porto Alegre

90035-903

Shionogi Research Site, Porto Alegre

97105-900

Shionogi Research Site, Santa Maria

04378-000

Shionogi Research Site, São Paulo

Unknown

Shionogi Research Site, Guatemala City

Shionogi Research Site, Ankara

Shionogi Research Site, Trabzon

Shionogi Research Site, London

480-1195

Shionogi Research Site, Nagakute

142-8999

Shionogi Research Site, Shinagawa-ku

852-8501

Shionogi Research Site, Nagasaki

06591

Shionogi Research Site, Seoul

06973

Shionogi Research Site, Seoul

07441

Shionogi Research Site, Seoul

135-710

Shionogi Research Site, Seoul

08035

Shionogi Research Site, Terrassa

08003

Shionogi Research Site, Barcelona

08025

Shionogi Research Site, Barcelona

08036

Shionogi Research Site, Barcelona

SE1 7EH

Shionogi Research Site, London

W 120NN

Shionogi Research Site, London

W12 0HS

Shionogi Research Site, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shionogi

INDUSTRY

NCT02714595 - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens | Biotech Hunter | Biotech Hunter