| CTRI Number |
CTRI/2023/06/053535 [Registered on: 05/06/2023] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Trial of Cefepime-Zidebactam in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis in Adults |
|
Scientific Title of Study
|
A Phase 3, Randomized, Double-blind, Multicenter, comparative Study to Determine the Efficacy and Safety of Cefepime-Zidebactam vs. Meropenem in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis in Adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT04979806 |
ClinicalTrials.gov |
| W-5222-301, Version 1.0 dated 04-SEP-2019 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr. Sachin Bhagwat |
| Designation |
Senior Vice-President, Drug Discovery |
| Affiliation |
Wockhardt Limited |
| Address |
D-4 MIDC, Chikalthana, Aurangabad
Aurangabad
MAHARASHTRA
431006
India |
| Phone |
02406694185 |
| Fax |
|
| Email |
sbhagwat@wockhardt.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr. Sachin Bhagwat |
| Designation |
Senior Vice-President, Drug Discovery |
| Affiliation |
Wockhardt Limited |
| Address |
D-4 MIDC, Chikalthana, Aurangabad
Aurangabad
MAHARASHTRA
431006
India |
| Phone |
02406694185 |
| Fax |
|
| Email |
sbhagwat@wockhardt.com |
|
|
Source of Monetary or Material Support
|
| Wockhardt Bio AG Grafenauweg 6 Zug-6300, Switzerland |
|
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Primary Sponsor
|
| Name |
Wockhardt Bio AG |
| Address |
Grafenauweg 6 Zug-6300, Switzerland |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
Bulgaria
China
Estonia
India
Lithuania
Mexico
Peru
Poland
Slovakia
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Apurva Dhirendra Parekh |
Aartham multi super speciality hospital |
, Opp polytechnic, NR panjarapole cross road, Ambawadi, Ahmedabad- 380005, India
Ahmadabad
GUJARAT |
9824542389
drapurvaparekh333@gmail.com |
| Dr Prashant Raghunath Potdar |
Accord Hospital |
Kendriya Vihar Road, Sector Number 4, Moshi, Pimpri-Chinchwad- 412105, Maharashtra, India
Pune
MAHARASHTRA |
8240213193
rkasar@ip-sl.com |
| Dr Suresh Balkrishna Patankar |
Ace Hospital and Research centre |
S.No. 32/2A, Erandwane, Gulwani Maharaj Path, Pune-411004
Pune
MAHARASHTRA |
9881256992
sureshpatankarace@gmail.com |
| DrYogesh Ashok Deogirikar |
Oriion Citicare Super Speciality Hospital |
5-5-70, Opp. Kalash Mangal Karyalaya, New Osmanpura, Aurangabad- 431005
Aurangabad
MAHARASHTRA |
9423238458
drdeoy@gmail.com |
| Dr Pratikshit Madhav Mahajan |
Supe Heart and Diabetes Hospital and Research Centre. |
Opp. Adhar Ashram, Near Rungta School, Gharpure Ghat, Ashok Stambh, Nashik- 422002
Nashik
MAHARASHTRA |
9881058580
Pratikshitm23@gmail.com |
| Dr Dhananjay Vinayak Selukar |
Super speciality Hospital, Government Medical College and Hospital |
Second floor, Research room, Department of Urology, Medical College Sqaure Road, Tukdoji Square, Nagpur – 440009, Maharashtra, India
Nagpur
MAHARASHTRA |
9225234197
vazirgmc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Aartham ethics committee |
Approved |
| Institutional Ethics committee Sangvi multispeciality hospital |
Approved |
| Institutional Ethics Committee-ACE Hospital |
Approved |
| Institutional of Ethics Committee, Government Medical College, Nagpur |
Approved |
| Oriion Citicare Hospital-Institutional Ethics Committee |
Approved |
| Supe Hospital Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cefepime-Zidebactam |
Dose - FEP-ZID 3 g (2 g cefepime + 1 g Zidebactam)
Route of administration - Intravenous
Frequency - Every eight hours Total duration - 7 to 10 days |
| Comparator Agent |
Meropenem |
Dose - 1 g
Route of administration - Intravenous Frequency - Every eight hours
Total duration - 7 to 10 days |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Male and female greater than or equal to 18 years of age. Provide a signed written informed consent prior to any study specific procedures. Meet the clinical criteria for either Complicated Urinary tract infection or Acute pyelonephritis. All females must have a negative Urine or Serum Pregnancy Test. |
|
| ExclusionCriteria |
| Details |
Known or suspected disease or condition that, in the opinion of the Investigator, may confound the assessment of efficacy. Receipt of potentially-effective systemic antibacterial therapy within 48 hours prior to randomization. Rapidly progressive or terminal illness with a high risk of mortality due to any cause. Pregnant or breastfeeding women. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
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Primary Outcome
|
| Outcome |
TimePoints |
| To demonstrate that Cefepime-Zidebactam (FEP-ZID) is non-inferior to Meropenem in percentage of subjects with overall success at test of cure visit. To assess percentage of subjects with treatment-emergent adverse event (TEAE) |
Test of cure visit- Day 17 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate percentage of subjects with clinical cure, microbiological eradication with overall success at various defined visits |
End of Treatment visit- 7 to 10 days
Follow Up Visit- 26 Days |
|
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Target Sample Size
|
Total Sample Size="504"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "530"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/07/2023 |
| Date of Study Completion (India) |
18/11/2024 |
| Date of First Enrollment (Global) |
29/08/2022 |
| Date of Study Completion (Global) |
25/11/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This is a Phase 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID vs. meropenem in the treatment of hospitalized adults with Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) in Adults. Subjects providing informed consent and meeting all study eligibility criteria will be enrolled in the study and randomised in a 1:1 ratio to either of the 2 treatment arms (FEP-ZID 3 g or Meropenem 1 g)
|