A Phase III, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK-0826/Ertapenem and Meropenem in Patients with Complicated Urinary Tract Infections

INTERVENTION: Trade Name: INVANZ Product Name: Invanz Product Code: J01DH03 Pharmaceutical Form: Powder for injection* INN or Proposed INN: Ertapenem Concentration unit: g gram(s) Concentration type: equal Concentration number: 1‐ Trade Name: MERONEM Product Name: Meronem Pharmaceutical Form: Powder for injection* INN or Proposed INN: meropenem Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ CONDITION: Complicated urinary tract infection ; MedDRA version: 9.1 Level: LLT Classification code 10046571 Term: Urinary tract infection PRIMARY OUTCOME: 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. 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.; 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. 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