A Study of Efficacy and Safety of Intravenous Cefiderocol (S-649266) Versus Imipenem/Cilastatin in Complicated Urinary Tract Infections

PHASE2CompletedINTERVENTIONAL
Enrollment

452

Participants

Timeline

Start Date

February 5, 2015

Primary Completion Date

July 26, 2016

Study Completion Date

August 16, 2016

Conditions
Urinary Tract Infections
Interventions
DRUG

Cefiderocol

2000 mg intravenously every 8 hours for 7 to 14 days; dose adjustments for participants with reduced renal function (estimated CrCl ≤ 70 mL/minute) and/or body weight (\< 70 kg) included every 6-hour dosing intervals and/or reduced doses.

DRUG

Imipenem/cilastatin

1000 mg of each intravenously every 8 hours for 7 to 14 days; dose adjustments for participants with reduced renal function (estimated CrCl ≤ 70 mL/minute) and/or body weight (\< 70 kg) included every 6-hour dosing intervals and/or reduced doses.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shionogi

INDUSTRY