Health Condition 1: N399- Disorder of urinary system, unspecified
Conditions
Interventions
Intervention1: INTRAVENOUS PLAZOMICIN: Intravenous Plazomicin 500mg/10mL (50 mg/mL) for 7 Days
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Parents or their legally acceptable representatives who voluntarily provide written informed consent. 2. Male or Female patients of age 18 years or older. 3. Patients with clinical diagnosis of cUTI, Including Acute Pyelonephritis (AP) suspected to be caused by susceptible microorganisms to Plazomicin vis E-Coli, Klebsiella Pneumoniae, Proteus Mirabillis, or Enterobacter cloacae will be recorded.
Exclusion criteria
Exclusion criteria: Known hypersensitivity to any aminoglycosides or any excipients. Calculated creatinine clearance at screening less than 15 ml per unit. Receipt of any dose of potentially therapeutic antibacterial agent within 48 hours prior to start of study therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of adverse events including serious adverse events, treatment emergent adverse events and nephrotoxicityTimepoint: At Baseline, Day 7, Day 14 and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response [cure / improvement / failure / indeterminate] at end of IV treatment [EOIV] and follow up visit [Day 14 and Day 28] Microbiological response [eradication / persistence / recurrence / indeterminate] at end of IV treatment [EOIV] and follow up visit [Day 14 and Day 28] Investigator s Global Assessment at end of IV treatmentTimepoint: Day 14 and Day 28 | — |
Countries
India
Contacts
Public ContactMr Rahul Namjoshi
Cipla Limited
Outcome results
None listed