A Study of Efficacy/Safety of Intravenous S-649266 Versus Imipenem/Cilastatin in Complicated Urinary Tract Infections (APEKS-cUTI)
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|ClinicalTrials.gov Identifier: NCT02321800|
Recruitment Status : Completed
First Posted : December 22, 2014
Last Update Posted : July 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infections||Drug: S-649266 Drug: Imipenem/cilastatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Uncomplicated Pyelonephritis Caused by Gram-Negative Pathogens in Hospitalized Adults in Comparison With Intravenous Imipenem/Cilastatin|
|Study Start Date :||December 1, 2014|
|Actual Primary Completion Date :||July 26, 2016|
|Actual Study Completion Date :||August 16, 2016|
2000 mg intravenously every 8 hours for a period of 7 to 14 days (dosage adjustment is necessary based on renal function and body weight)
Other Name: cefiderocol
|Active Comparator: Imipenem/cilastatin||
1000 mg intravenously every 8 hours for a period of 7 to 14 days (dosage adjustment is necessary based on renal function and body weight)
- 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) ]Clinical and Microbiologic Response: Resolution or improvement of the symptoms of cUTI present at trial entry (and no new symptoms) and the demonstration that the bacterial pathogen found at trial entry is reduced to fewer than 10^4 CFU/mL on urine culture at the TOC (microbiological success).
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321800
|Study Director:||Shionogi Clinical Trials Administrator Clinical Support Help Line||Shionogi|