CTRI

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CTRI Number

CTRI/2025/04/084753 [Registered on: 15/04/2025] Trial Registered Prospectively

Last Modified On:

03/09/2026

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Non-randomized, Active Controlled Trial

Public Title of Study

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

Scientific Title of Study

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

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
CP/01/24, Version 01 Dated 29/04/2024	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Jaideep Gogtay
Designation	Global Cheif Medical officer
Affiliation	Cipla Limited
Address	Cipla Ltd, Dept: Medical Services, Division: Clinical Trials, Room No. NA, 289 Bellasis Road, Mumbai Central, Mumbai- 400008 Maharashtra, India Mumbai MAHARASHTRA 400008 India
Phone	02223025145
Fax
Email	jgogtay@cipla.com

Details of Contact Person
Scientific Query

Name	Dr Sandesh Sawant
Designation	Head- Clinical Trials
Affiliation	Cipla Limited
Address	Cipla Ltd, Dept: Medical Services, Division: Clinical Trials, Room No. NA, 289 Bellasis Road, Mumbai Central, Mumbai- 400008 Maharashtra, India Mumbai MAHARASHTRA 400008 India
Phone	02223025006
Fax
Email	sandesh.sawant3@cipla.com

Details of Contact Person
Public Query

Name	Mr Rahul Namjoshi
Designation	Senior Manager, Clinical Trials
Affiliation	Cipla Limited
Address	Cipla Ltd, Dept: Medical Services, Division: Clinical Trials, Room No. NA, 289 Bellasis Road, Mumbai Central, Mumbai- 400008 Maharashtra, India Mumbai MAHARASHTRA 400008 India
Phone	02223025145
Fax
Email	rahul.namjoshi@cipla.com

Source of Monetary or Material Support

Cipla Ltd, 289 Bellasis Road, Mumbai Central, Mumbai, Maharashtra, 400008, India

Primary Sponsor

Name	Cipla Ltd
Address	Cipla Ltd, 289 Bellasis Road, Mumbai Central, Mumbai, Maharashtra, 400008, India
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 15
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Noushadali Shaik	AC Subba Reddy Government Medical College and Hospital	General Medicine Department, GT Road, Dargamitta, opp. Dsr Govt hospital, Nellore, Andhra Pradesh 524004 Nellore ANDHRA PRADESH	9494828694 mddbnoal@gmail.com
Dr Lavanya Raghu Sarath P	ADITYA MULTI SPECIALITY HOSPITAL	13-3-52 , 3rd Line ,Gunturivari Thota, Kothapet Beside Peoples Trauma Guntur Guntur Andhra Pradesh - 522001 India Guntur ANDHRA PRADESH	9000210310 drraghusarath29@gmail.com
Dr Amit Sharma	AIIMS Hospital, Raipur	Urology Department, C Block, Ground Floor, Gate No 1, Great Eastern Rd, opposite Gurudwara, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099 Raipur CHHATTISGARH	8691898668 dramiturology@gmail.com
Dr Anup Warrier	Aster medcity Hospital	Kuttisahib Road Cheranelloor, South Chittoor, Kochi, Kerala 682027 Ernakulam KERALA	9745012477 dranup.warrier@asterdmhealthcare.com
Dr Diwakar TN	Bangalore Medical College and Research Institute, Victoria Hospital, Bangalore	Bangalore Medical College and Research Institute, Department of Medicine, 67/A, First Floor, C Block, Victoria Hospital, Fort, KR Road, Bengaluru 560002 Bangalore KARNATAKA	9844130534 dr.diwakartn@gmail.com
Dr Shrenik Shah	BJ Medical College and Civil Hospital	Department of Urology, 84 Ward, Civil Hospital, Haripura, Asarwa, Ahmedabad, Gujarat 380016 Ahmadabad GUJARAT	9824086834 drshreniks@gmail.com
Dr Santosh Gattu	Continental Hospital	Department of Infectious DIsease, Plot No. 3, Road No. 2, IT and Financial District, Nanakramguda, Gachibowli, Hyderabad, Telangana, 500032 Hyderabad TELANGANA	7569962770 drsantosh.g@continentalhospitals.com
Dr Sanjeet Singh	Dr. Ram Manohar Lohia Institute of Medical Sciences	Urology Department, OPD Building, 2nd floor, Vibhuti Khand, Gomti Nagar, Lucknow, Uttar Pradesh 226010 Lucknow UTTAR PRADESH	8176007229 sanjeetsingh1982@yahoo.in
Dr Subramanian Swaminathan	Gleneagles Hospital	439 Sholinganallur, Cheran Nagar Chennai, TamilNadu 600100 Chennai TAMIL NADU	9551068575 - drsubramanians@gmail.com
Dr Vinay Kumar	GSVM MEDICAL COLLEGE	Department of Medicine, Ward No. 15, Research Room, LLR Hospital, SWAROOP NAGAR,Kanpur, Uttar Pradesh -208002 India Kanpur Nagar UTTAR PRADESH	9839071553 vinaysinghkgmc99@gmail.com
Dr Bhagyesh Shah	Marengo CIMS Hospital, Ahmedabad	Department of Critical Care and Pulmonary Care, Plot No. 67/1, Opposite panchamrut Bunglow, Near Shukan Mall, Science City Road, Sola, Ahmedabad, Gujarat 380060 Ahmadabad GUJARAT	9099068938 bhagyesh.shah@marengoasia.com
Dr Dilip Dubey	Medanta Hospital	Critical Care Unit, Sector-A, Pocket-1, Sushant Golf City, Shaheed Path, Lucknow, Uttar Pradesh - 226030 Lucknow UTTAR PRADESH	9369047990 dilip.dubey@medanta.org
Dr Yatin Mehta	Medanta The Medcity Hospital, Gurgaon	Anaesthesiology and Critical Care department, CH Baktawar Singh Road, Sector 38, Gurugram, Haryana 122001 Gurgaon HARYANA	9971698149 yatin.mehta@medanta.org
Dr Pratikshit Mahajan	Supe Heart and Diabetes Hospital and Research Centre	Opp Aadhar Ashram, Near Rungtha School, Gharpureghat, Ashok Stambh Nashik, 422002 Nashik MAHARASHTRA	9881058580 rhlpatil@yahoo.com
Dr Soumyadip Chatterji	Tata Medical Center	14, MAR(E-W), DH Block (Newtown) Action Area I, Newtown, Kolkata- 700160, India Kolkata WEST BENGAL	9051851337 - soumyadip.chatterji@tmckolkata.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 14
Name of Committee	Approval Status
Ethics Committee Bangalore Medical College and Research Institute	Approved
ETHICS COMMITTEE GSVM MEDICAL COLLEGE KANPUR	Approved
Ethics Committee of Marengo Asia Healthcare Pvt. Ltd., Ahmedabad, Gujarat	Approved
IEC ADITYA MULTI SPECIALITY HOSPITAL	Approved
INSTITUTE ETHICS COMMITTEE, AIIMS RAIPUR	Approved
Institution Ethics Committee Continental Hospital	Approved
Institutional Ethics Committee	Approved
Institutional Ethics Committee AC Subba Reddy Medical College	Approved
INSTITUTIONAL ETHICS COMMITTEE BJ Medical	Approved
Institutional Ethics Committee Gleneagles	Approved
Institutional Ethics Committee Medanta Lucknow	Approved
Institutional Review Board TMC	Approved
Medanta Institutional Ethics Committee	Approved
Supe Hospital Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: N399\|\|Disorder of urinary system, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	INTRAVENOUS PLAZOMICIN	Intravenous Plazomicin 500mg/10mL (50 mg/mL) for 7 Days
Comparator Agent	Not Applicable	Not Applicable

Inclusion Criteria

Age From	18.00 Year(s)
Age To	75.00 Year(s)
Gender	Both
Details	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.

ExclusionCriteria

Details

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.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Assessment of adverse events including serious adverse events, treatment emergent adverse events and nephrotoxicity	At Baseline, Day 7, Day 14 and Day 28

Secondary Outcome

Outcome	TimePoints
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 treatment	Day 14 and Day 28

Target Sample Size

Total Sample Size="135"
Sample Size from India="135"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 4

Date of First Enrollment (India)

28/04/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

After a written, signed, dated informed consent is obtained, adult subjects with cUTI and/or AP will be screened for eligibility to participate in the study. Patients with a clinical diagnosis of cUTI, and/or AP, deemed to benefit from plazomicin will receive treatment with Plazomicin IV once daily. During screening period samples of urine and/blood of patients will be sent for culture and antibiotic sensitivity analysis while Plazomicin will be initiated. Plazomicin will be continued for 4 to 7 days in those patients in whom culture report shows sensitivity to Plazomicin [microorganism: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis or Enterobacter cloacae]. Follow-up visits at day 14 and day 28 from first dose of the IV treatment will be conducted for those who complete the IV treatment. Patients will be assessed throughout the treatment period (as appropriate) and at follow-up visit. A range of observations will be recorded, including clinical, microbiological and safety assessments. Adverse events will be monitored throughout the study period.