Clinical Trial: A Study of Efficacy/Safety of Intravenous S-649266 Versus Imipenem/Cilastatin in Complicated Urinary Tract Infections
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter, Double-blind, Randomized, Clinical Study to Assess the Efficacy and Safety of Intravenous S-649266 in Complicated Urinary Tract Infections With or Without Pyelonephritis or Acute Uncomp
Brief Summary: To determine the efficacy and safety of intravenous S-649266 in hospitalized adults with complicated urinary tract infections caused by Gram-negative pathogens.
Detailed Summary: The purpose of this study is to determine the efficacy and safety of intravenous S 649266 versus intravenous imipenem/cilastatin in hospitalized adults with complicated urinary tract infections with or without pyelonephritis or acute uncomplicated pyelonephritis caused by Gram-negative pathogens.
Sponsor: Shionogi
Current Primary Outcome: Composite of Clinical Cure and Microbiologic Eradication [ Time Frame: Baseline and at Test of Cure (TOC; 7 days after end of treatment [EOT], equivalent to Study Day 14-21) ]
Original Primary Outcome: Clinical and Microbiologic Response [ Time Frame: Baseline and at Test of Cure (TOC; 7 days after end of treatment [EOT], equivalent to Study Day 14-21) ]
Current Secondary Outcome:
- Microbiologic response per pathogen and per patient at early assessment (EA), EOT, TOC, and follow-up (FUP) [ Time Frame: Baseline and Early Assessment (EA; Day 4), EOT (Day 7-14), TOC (Day 14-21), and at Follow-up (FUP; 14 days after end of treatment; equivalent to Study Days 21-28) ]Eradication in microbiological outcomes (microbiological success), where eradication is defined as a urine culture that shows the bacterial uropathogen(s) found at entry at ≥ 10^5 CFU/mL are reduced to < 10^4 CFU/mL. A microbiological response per pathogen will be determined for each pathogen isolated at baseline. A microbiological response per patient will be determined for each patient based on individual responses.
- Clinical response per pathogen and per patient at EA, EOT, TOC, and FUP [ Time Frame: Baseline and EA (Day 4), EOT (Day 7-14), TOC (Day 14-21), and FUP (Days 21-28) ]Clinical cure in clinical outcomes (resolution of the signs and symptoms of complicated urinary tract infection [cUTI] or return to pre-infection baseline if known). A clinical response per pathogen will be determined for each pathogen isolated at baseline. A clinical response per patient will be determined for each patient based on individual responses.
- Plasma concentration of S-649266 [ Time Frame: On Day 3 of dosing; plasma sampling prior to infusion, within 15 minutes prior to end of infusion, and at 2 hours post infusion ]Plasma concentration of S-649266 at steady state
- Urine concentrations of S-649266 [ Time Frame: Urine sampling 2 hours and 6 hours after end of infusion ]Urine concentration of S-649266 at steady state
- Number of participants with adverse events [ Time Frame: From Baseline to the Safety Follow-up visit 28 days after end of treatment; equivalent to study Day 35 to 42 ]
Original Secondary Outcome:
- Microbiologic response per pathogen and per patient at early assessment (EA), EOT, TOC, and follow-up (FUP) [ Time Frame: Baseline and Early Assessment (EA; Day 4), EOT (Day 7-14), TOC (Day 14-21), and at Follow-up (FUP; 14 days after end of treatment; equivalent to Study Days 21-28) ]Eradication in microbiological outcomes (microbiological success), where eradication is defined as a urine culture that shows the bacterial uropathogen(s) found at entry at ≥ 10^5 CFU/mL are reduced to < 10^4 CFU/mL. A microbiological response per pathogen will be determined for each pathogen isolated at baseline which may include Pseudomonas aeruginosa; Acinetobacter baumannii; Enterobacteriaceae. A microbiological response per patient will be determined for each patient based on individual responses.
- Clinical response per pathogen and per patient at EA, EOT, TOC, and FUP [ Time Frame: Baseline and EA (Day 4), EOT (Day 7-14), TOC (Day 14-21), and FUP (Days 21-28) ]Clinical cure in clinical outcomes (resolution of the signs and symptoms of complicated urinary tract infection [cUTI] or return to pre-infection baseline if known). A clinical response per pathogen will be determined for each pathogen isolated at baseline, which may include Pseudomonas aeruginosa; Acinetobacter baumannii; Enterobacteriaceae. A clinical response per patient will be determined for each patient based on individual responses.
- Plasma concentration of S-649266 [ Time Frame: On Day 3 of dosing; plasma sampling prior to infusion, within 15 minutes prior to end of infusion, and at 2 hours post infusion ]Plasma concentration of S-649266 at steady state
- Urine concentrations of S-649266 [ Time Frame: Urine sampling 2 hours and 6 hours after end of infusion ]Urine concentration of S-649266 at steady state
- Number of participants with adverse events [ Time Frame: From Baseline to the Safety Follow-up visit 28 days after end of treatment; equivalent to study Day 35 to 42 ]
Information By: Shionogi Inc.
Dates:
Date Received: November 11, 2014
Date Started: December 1, 2014
Date Completion:
Last Updated: April 18, 2017
Last Verified: April 2017