Intravenous Plazomicin study for the treatment of complicated urinary tract infection (cUTI), including Acute Pyelonephritis (ap), in adults

Phase 4

Not yet recruiting

• Conditions: Disorder of urinary system, unspecified,

• Registration Number: CTRI/2025/04/084753
• Lead Sponsor: Cipla Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-28
• Last Update Posted: 2025-05-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

• Parents or their legally acceptable representatives who voluntarily provide written informed consent.
• Male or Female patients of age 18 years or older.
• 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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of adverse events including serious adverse events, treatment	At Baseline, Day 7, Day 14 and Day 28
emergent adverse events and nephrotoxicity	At Baseline, Day 7, Day 14 and Day 28

Secondary Outcome Measures

Name	Time	Method
Clinical response [cure / improvement / failure / indeterminate] at end of IV	treatment [EOIV] and follow up visit [Day 14 and Day 28]

Trial Locations

Locations (4)

AIIMS Hospital, Raipur; 🇮🇳 Raipur, CHHATTISGARH, India

BJ Medical College and Civil Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

GSVM MEDICAL COLLEGE; 🇮🇳 Nagar, UTTAR PRADESH, India

Marengo CIMS Hospital Private Limited; 🇮🇳 Ahmadabad, GUJARAT, India

AIIMS Hospital, Raipur

🇮🇳Raipur, CHHATTISGARH, India

Dr Amit Sharma

Principal investigator

8691898668

dramiturology@gmail.com