Complicated urinary tract infection MedDRA version: 9.1 Level: LLT Classification code 10046571 Term: Urinary tract infection
Conditions
Interventions
Trade Name: INVANZ
Product Name: Invanz
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: Ertapenem
Concentration unit: g
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient has a clinically suspected and /or bacteriologically documented complicated UTI or acute pyelonephritis judged by the investigator to be serious. Patient has one positive urine culture within 48 hours of enrollment. Patient has one or more signs or symptoms of either upper or lower UTI. Patient is male with or without a bladder catheter or urologic abnormalities; OR patient is a female with a history or clinical evidence of one or more urologic abnormalities. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient has received any amount of effective concomitant antibiotic therapy after obtaining the urine culture for admission to this study (admission urine culture) and prior to the administration of the first dose of study antibiotics. Patient's infection has been treated with greater than 24 hours of systemic antibiotic therapy known to be effective against the presumed or documented pathogens within the 72 hour period immediately prior to consideration for entry into the study. Patient has complete obstruction of any portion of the urinary tract. Patient has a history of seizures other than an uncomplicated febrile seizure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To compare the efficacy of ertapenem with respect to the overall microbiological response assessment profile in the treatment of patients with serious (requiring hospitalization and treatment with parenteral therapy) complicated UTIs, including acute pyelonephritis, with that of the meropenem control group at the 5 to 9 days posttherapy (EFU/TOC) follow-up visit. 2) To compare the efficacy of ertapenem with respect to the clinical response assessment profile in the treatment of patients with serious complicated UTIs, including acute pyelonephritis, with that of the meropenem control group at completion of parenteral therapy (DCIV). 3) To compare the efficacy of ertapenem with respect to the overall microbiological response assessment profile in the treatment of patients with serious complicated UTIs, including acute pyelonephritis, with that of the meropenem control group at DCIV. 4) To evaluate the safety profile of ertapenem at DCIV.;Secondary Objective: 1) To compare the efficacy of ertapenem with respect to the overall clinical response assessment profile in the treatment of patients with serious complicated UTIs, including acute pyelonephritis, with that of the meropenem control group at the 5 to 9 days posttherapy (EFU/TOC) follow-up visit. 2) To compare the efficacy of ertapenem with respect to the proportion of patients with sustained microbiological and clinical response in the treatment of patients with serious complicated UTIs, including acute pyelonephritis, with that of the meropenem control group, measured at the LFU visit.; Primary end point(s): Favorable microbiological response assessment at the EFU/TOC visit. Favorable clinical response assessment at DCIV. Favorable microbiological response assessment at DCIV. | — |
Countries
Bulgaria, France, Spain
Outcome results
None listed