| CTRI Number |
CTRI/2025/04/084753 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
No |
| 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
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| 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 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 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 Private Limited |
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 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= 7 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GSVM MEDICAL COLLEGE KANPUR |
Approved |
| Ethics Committee of CIMS |
Approved |
| INSTITUTE ETHICS COMMITTEE, AIIMS RAIPUR |
Submittted/Under Review |
| Institutional Ethics Committee |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE BJ Medical |
Submittted/Under Review |
| Institutional Ethics Committee Gleneagles |
Approved |
| Institutional Review Board TMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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. |