A Multicentre, Open Label, Non-comparative, Phase 4 study to evaluate the safety and efficacy of intravenous Plazomicin for the treatment of complicated urinary tract infection (cUTI), including Acute Pyelonephritis (AP), in adults

After a written, signed, dated informed consent isobtained, adult subjects with cUTI and/or AP will be screened for eligibilityto participate in the study. Patientswith a clinical diagnosis of cUTI, and/or AP, deemed to benefit from plazomicinwill receive treatment with Plazomicin IV once daily. During screening periodsamples of urine and/blood of patients will be sent for culture and antibioticsensitivity analysis while Plazomicin will be initiated. Plazomicin will becontinued for 4 to 7 days in those patients in whom culture report showssensitivity to Plazomicin [microorganism: Escherichia coli, Klebsiellapneumoniae, Proteus mirabilis or Enterobacter cloacae]. Follow-up visits atday 14 and day 28 from first dose of the IV treatment will be conducted forthose who complete the IV treatment. Patients will be assessed throughout thetreatment period (as appropriate) and at follow-up visit. A range ofobservations will be recorded, including clinical, microbiological and safetyassessments. Adverse events will be monitored throughout the study period.