Conditions: Urinary Tract Infections
Keywords: S-649266 complicated urinary tract infection cefiderocol acute uncomplicated pyelonephritis Gram-negative pathogens imipenem/cilastatin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 452
Healthy volunteers: no

Brief summary:
The purpose of this study was to determine the efficacy and safety of intravenous cefiderocol (S-649266) in hospitalized adults with complicated urinary tract infections caused by Gram-negative pathogens.

Detailed description:

Arms:
arm 1: Participants received 2 g cefiderocol by intravenous injection once every 8 hours for 7 to 14 days. arm 2: Participants received 1 g each of imipenem/cilastatin by intravenous injection once every 8 hours for 7 to 14 days.

Interventions: intervention 1: Cefiderocol intervention 2: Imipenem/cilastatin
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: