EUCTR2014-000914-76-DE
Active, not recruiting
Phase 1
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
ConditionsComplicated Urinary Tract Infections with or without Pyelonephritis or Acute Uncomplicated Pyelonephritis caused by Gram-negative PathogensMedDRA version: 19.0Level: HLTClassification code 10046577Term: Urinary tract infectionsSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
DrugsTienam
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
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 hypertrophy
- •Urine retention of at least 100 millileters (mL) or more of residual
- •urine after voiding (neurogenic bladder)
- •Obstructive uropathy (nephrolithiasis, fibrosis, etc.)
- •Azotemia caused by intrinsic renal disease (BUN and creatinine values
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Not specified
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