None listed
Conditions
Interventions
Approximately 850 subjects who have a clinical diagnosis of cUTI or AP, meet all inclusion/exclusion criteria, and have clinical severity of illness to warrant the use of IV antibiotics for at least 5
Sponsors
REMPEX PHARMACEUTICALS Inc. subsidiaria de propiedad total de The Medicines Company,
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. A signed informed consent form, the ability to understand the study conduct and tasks that are required for study participation, and a willingness to cooperate with all tasks, tests, and examinations as required by the protocol. 2. Male or female 18 years of age. 3. Weight 150 kg. 4. Expectation, in the judgment of the Investigator, that the subject’s cUTI or AP requires initial treatment with at least 5 days of IV antibiotics. 5. Documented or suspected cUTI or AP as defined in the chart Expectation, in the judgment of the Investigator, that any indwelling urinary catheter or instrumentation (including nephrostomy tubes and/or indwelling stents) will be removed or replaced (if removal is not clinically acceptable) before or as soon as possible, but not longer than 12 hours, after randomization. 7. Expectation, in the judgment of the Investigator, that the subject will survive with effective antibiotic therapy and appropriate supportive care for the anticipated duration of the study. 8. Women of childbearing potential must have a negative pregnancy test before randomization and be willing to use a highly effective method of contraception between randomization and for 7 days after the completion of the study. 9. Willingness to comply with all the study procedures, whether in the hospital or after discharge, for the duration of the study.
Exclusion criteria
Exclusion criteria: For additional exclusion criteria please refer to the protocol. 1. Presence of any of the following conditions: a. Perinephric abscess; b. Renal corticomedullary abscess; c. Uncomplicated UTI; d. Polycystic kidney disease; e. Chronic vesicoureteral reflux; f. Previous or planned renal transplantation; g. Subjects receiving hemodialysis; h. Previous or planned cystectomy or ileal loop surgery; or i. Known candiduria. 2. Presence of acute bacterial prostatitis, orchitis, epididymitis, or chronic bacterial prostatitis as determined by history and/or physical examination. 3. Gross hematuria requiring intervention other than administration of study drug. 4. Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period (except surgery required to relieve an obstruction or place a stent or nephrostomy). 5. Renal function at screening as estimated by creatinine clearance <30 mL/min using the Cockcroft-Gault formula. 6. Known non-renal source of infection such as endocarditis, osteomyelitis, abscess, meningitis, or pneumonia diagnosed within 7 days prior to randomization. 7. Any of the following signs of severe sepsis
Countries
Argentina, Australia, Austria, Brazil, Bulgaria, China, Colombia, Czech Republic, Germany, Greece, Hungary, Israel, Italy, Korea South, Poland, Romania, Russian Federation, Slovakia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Ukraine, United Kindgdom, United States
Contacts
Public ContactJose Eduardo Gotuzzo
GOTUZZO ASOCIADOS S.A.C.
Outcome results
None listed