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

Shionogi Inc.0 sites450 target enrollmentAugust 11, 2014

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Complicated Urinary Tract Infections with or without Pyelonephritis or Acute Uncomplicated Pyelonephritis caused by Gram-negative Pathogens
Sponsor: Shionogi Inc.
Enrollment: 450
Status: Active, not recruiting
Last Updated: 9 years ago

No summary available.

Registry

who.int

Start Date

August 11, 2014

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Hospitalized patients who have a clinical diagnosis of either cUTI with or without pyelonephritis or acute uncomplicated pyelonephritis, and who have provided written informed consent or informed consent provided by legal guardian. (Note: Country specific rules and local Ethics Committee approval for legal guardian informed consent will determine whether or not a patient unable to comprehend or sign the informed consent is allowed to be enrolled in the study).
•The specific clinical diagnosis will include:
•cUTI with a history of at least one of the following:
•Indwelling urinary catheter or recent instrumentation of the urinary tract (within 14 days prior to screening)
•Urinary retention caused by benign prostatic hypertophy
•Urinary retention of at least 100 millileters (mL) or more of residual urine after voiding (nerurogenic bladder)
•Obstructive uropathy (nephrolithiasis, fibrosis, etc.)
•Azotemia caused by instrinsic renal disease (BUN and creatinine values greater than normal laboratory values)
•Pyelonephritis and normal urinary tract anatomy, ie, acute uncomplicated pyelonephritis
•All patients must have at least two of the following signs or symptoms:

•1\. Have a history of hypersensitivity reactions to carbapenems, cephalosporins, penicillins, or other ß\-lactam antibiotics
•2\. Patient's urine culture at study entry isolates more than 2 uropathogens, regardless of colony count, or patient has a confirmed fungal UTI.
•3\. Patients with asymptomatic bacteriuria, the presence of \=100000CFU/mL of a uropathogen and pyuria but without local or systemic symptoms
•4\. Patient is receiving hemodialysis or peritoneal dialysis. Impairment of renal function with an estimated CrCl \< 21 mL/min, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (\< 20 mL/h urine output over 24 hours).