CTRI/2024/04/065043 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On:
16/10/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
Clinical Trial of Cefepime-Zidebactam (FEP-ZID) for the Treatment of Adult Subjects with Serious bacterial Infections
Scientific Title of Study
A Phase 2, Prospective, Multi-Center Study to Determine the Efficacy and Safety of Cefepime-Zidebactam (FEP-ZID) WCK 5222 for the Treatment of Adult Subjects with Serious Infections Caused by Carbapenem-Resistant Gram-Negative Bacteria
including those with Underlying Kidney Dysfunction Precluding the Use of Colistin/Polymyxin B
Trial Acronym
No
Secondary IDs if Any
Secondary ID
Identifier
W-5222-202, Protocol Version 1.0 dated 05 Dec 2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Dr Sachin Bhagwat
Designation
Senior Vice-President
Affiliation
Wockhardt Research Centre
Address
Division - Drug Discovery Research
Department- Microbiology
D-4 MIDC, Chikalthana, Aurangabad
Aurangabad MAHARASHTRA 431006 India
Phone
02406694185
Fax
Email
sbhagwat@wockhardt.com
Details of Contact Person Public Query
Name
Dr Sachin Bhagwat
Designation
Senior Vice-President, Drug Discovery
Affiliation
Wockhardt Research Centre
Address
Division - Drug Discovery Research
Department- Microbiology
D-4 MIDC, Chikalthana, Aurangabad
Aurangabad MAHARASHTRA 431006 India
Phone
02406694185
Fax
Email
sbhagwat@wockhardt.com
Source of Monetary or Material Support
Wockhardt Research Centre,
D-4 MIDC, Chikalthana, Aurangabad-431006, Maharashtra, India
Room number 133, First floor, Department of Medicine, B block, OPD building, Marudhar Industrial Area, Basni, Basni, Jodhpur, Rajasthan 342005 Jodhpur RAJASTHAN
9116396922
deepak1007sharma@gmail.com
Dr P Vishnu Rao
Apollo Hospitals
Room number 56, Main block, Ground Floor, Apollo Hospitals, Apollo Health City Campus, Jubilee Hills, Hyderabad, Telangana – 500096, India Hyderabad TELANGANA
 78-79 Dhuleshwar Garden Behind HSBC Bank Sardar Patel Marg C-Scheme Jaipur-302001 Rajasthan India
Jaipur RAJASTHAN
911414039432
drmkalla@rediffmail.com
Dr Rajiv Karthik K
Christian Medical College
SP Complex, 4th floor, Department of Infectious Disease, IDA Scudder Rd, Vellore, 632004, India Vellore TAMIL NADU
6384044936
rajiv@cmcvellore.ac.in
Dr Rahul Sonawane
Eras Bharati Hospital
 Eras Bharti Hospital, Ganesham Commercial, A Building,floor 3rd & 4th, BRT Link Road, Pimple Saudagar, Pune 411027 Pune MAHARASHTRA
9420705185
drrahulsonawanesk@gmail.com
Dr Tirlangi Praveen Kumar
Kasturba Medical College
Room No.12, Infectious Disease Block, Ground Floor, KASTURBA MEDICAL COLLEGE
MANIPAL ACADEMY OF HIGHER EDUCATION
MADHAV NAGAR, MANIPAL-576104, Karnataka, INDIA
Udupi KARNATAKA
9868005784
praveenkuma.124@gmail.com
MUHAMMED NIYAS V K
KIMSHEALTH,TRIVANDRUM
KIMSHEALTH,PB NO-1,ANAYARA PO,TRIVANDRUM 695029,KERALA
Thiruvananthapuram KERALA
9446218291 9446218291 niyas987@gmail.com
Dr Vasant Nagvekar
Lilavati Hospital & Research Centre
1st floor, Department of Medicine, Lilavati Hospital & Research Centre
A-791, Bandra Reclamation, Bandra west, Mumbai- 400050,Maharashtra, India Mumbai MAHARASHTRA
9820055178 9820055178 drnagvekar@gmail.com
Dr Narendra Prasad C
Manipal Hospital
Dr Narendra Prasad C’s Cabin, Adjacent to ICU, Second Floor, 98 Old Airport Road, Bengaluru -560017, INDIA Bangalore KARNATAKA
7259733366
np71421@gmail.com
Dr Dilip Kumar Dubey
Medanta Hospital
Second floor, OPD, A wing, Sector-A, Pocket-1, Sushant Golf City, Amar Shaheed Path, Lucknow, Uttar Pradesh-226030 Lucknow UTTAR PRADESH
Dose - FEP-ZID 3 g (2 g
cefepime + 1 g Zidebactam)
Route of administration -
Intravenous Frequency - Every
eight hours Total duration - 7 to
21 days
Comparator Agent
Not Applicable
Not Applicable
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
Male and female of 18 to 75 years of age.
Provide a signed written informed consent prior to any study specific procedures.
Meet the clinical criteria for Following infections caused by documented Carbapenem-Resistant Gram-negative Bacteria
- Hospital-acquired Bacterial Pneumonia (HABP)/Ventilator-associated Bacterial
Pneumonia (VABP) ± concurrent Bloodstream Infection (ccBSI) or
- Complicated Intra-abdominal Infection (cIAI) ± ccBSI or
- Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) ± ccBSI
All females must have a negative Urine or Serum Pregnancy Test.
ExclusionCriteria
Details
Subjects with any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
Receipt of potentially-effective systemic antibacterial therapy with potential activity
against carbapenem-resistant Gram-negative bacteria within 48 hours during the 72 hours prior to treatment initiation.
Pregnant or breastfeeding women.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To assess the clinical outcome of treatment with FEP-ZID at test of cure (TOC)
Test of Cure visit - Day 28
Secondary Outcome
Outcome
TimePoints
To evaluate percentage of subjects with clinical
cure, microbiological eradication, all-cause mortality (ACM), safety and tolerability
Visit day 14
Visit Day 28
End of treatment - Between Day 7 to Day 21
Test of cure-Day 28
Follow up- Day 35
Target Sample Size
Total Sample Size="60" Sample Size from India="60" Final Enrollment numbers achieved (Total)= "72" Final Enrollment numbers achieved (India)="72"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a Phase 2, Prospective, Multi-Center
Study to Determine the Efficacy and Safety of Cefepime-Zidebactam (FEP-ZID) WCK
5222 for the Treatment of Adult Subjects with Serious Infections Caused by
Carbapenem-Resistant Gram-Negative Bacteria including those with
Underlying Kidney Dysfunction Precluding the Use of Colistin/Polymyxin
B. Subjects providing informed consent and meeting all study eligibility
criteria will be enrolled in the study FEP-ZID 3 g (2 g cefepime + 1 g Zidebactam).