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CTRI Number  CTRI/2024/04/065903 [Registered on: 18/04/2024] Trial Registered Prospectively
Last Modified On: 26/04/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Other (Specify) [PEM]  
Study Design  Single Arm Study 
Public Title of Study   Real world study to evaluate the safety and efficacy of NUWOK tab and Injection in the patients have infection. 
Scientific Title of Study   A Prospective, Prescription Event Monitoring (PEM) of NUWOK® (Levonadifloxacin injection) and/or NUWOK-O® (Alalevonadifloxacin tablet) to evaluate the safety and effectiveness in real-world setting 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
WOC/NUW/PEM-02/24 ver.01 date 01 feb.2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yogesh Vaidya 
Designation  Principal Investigator 
Affiliation  Pinnacle Ortho Centre Hospital 
Address  5/601, Accolade Chs, Hajuri Darga Road, Thane, 400604
1st and 2nd floor, Blue Nile, Chandanwadi signal, Panchpakhadi, Thane-400601
Thane
MAHARASHTRA
400604
India 
Phone  9820183881  
Fax    
Email  dryogeshv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrPurushotham 
Designation  Medical Monitor 
Affiliation  Wockhardt Ltd 
Address  Wockhardt Ltd. Wockhardt Tower, BKC, Bandra East, Mumbai-400051

Mumbai
MAHARASHTRA
400 051
India 
Phone  9739270420  
Fax    
Email  purushothamVS@wockhardt.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Khokan Debnath 
Designation  Senior General Manager (Head) – RA, Clinical Operations, PV and QA (India and Emerging Market) 
Affiliation  Wockhardt Ltd 
Address  Wockhardt Ltd. Wockhardt Tower, BKC, Bandra East, Mumbai-400051

Mumbai
MAHARASHTRA
400051
India 
Phone  02226596407  
Fax    
Email  kdebnath@wockhardt.com  
 
Source of Monetary or Material Support  
Wockhardt Ltd, Wockhardt Tower, BKC, Bandra East-Mumbai-400051 
 
Primary Sponsor  
Name  Wockhardt Ltd 
Address  Wockhardt Tower, BKC, Bandra East-Mumbai-400051 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yogesh Vaidya  Pinnacle Ortho Centre Hospital  1st and 2nd floor, Blue Nile, Chandanwadi, signal, Panchpakhadi, Thane-west-400601
Thane
MAHARASHTRA 		 9820183881

dryogeshv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), D.Y. Patil Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M01X||Direct infection of joint in infectious and parasitic diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  NUWOK Injection and NUWOK Tablet  NUWOK Injection (Levonadifloxacin 800mg/100 ml) NUWOK Tablet 500 mg Dose: NUWOK Injection 800mg/100ml twice a day. NUWOK Tab. oral 1000 mg twice a day. Duration 28 days or as per PI discretion. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patient age 18 years or above 18 years.
2. willing to patriciate in the study and provide inform consent.
3. Patients diagnosed with bone and joint infection. 
 
ExclusionCriteria 
Details  1. patients with history of hypersensitivity of drug and same class of drug.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 Understanding the prescription pattern of NUWOK in orthopedic setting
2 Evaluate safety profile of NUWOK in patients under orthopedic setting
3 Incidence of adverse events
4 Overall Global Assessment for Safety
 		 day 4 and day 28 or EOT 
 
Secondary Outcome  
Outcome  TimePoints 
1 Clinical Success Rate at EOT
2 Clinical Responder Rate / Clinical improvement rate at EOT
3 Clinical Responder Rate / Clinical improvement rate at Early assessment (Day
4±2)
4 Microbiological Success Rate
5 Overall Global Assessment for Efficacy
 		 day 4 and day 28 or EOT 
 
Target Sample Size   Total Sample Size="10000"
Sample Size from India="10000" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   23/04/2024 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   This is a prospective and multi-centric prescription event monitoring (PEM) surveillance in patients who have been prescribed with either NUWOK® or NUWOK O® or both either for prophylactic use in bone & joint surgery OR as a post-operative prophylaxis OR as a treatment for prosthetic joint infection, osteomyelitis or any kind of bone and joint infection . Eligible patients will be identified by the investigator / physician based on selection criteria. All the patients must have received NUWOK® or NUWOK O ® in routine clinical practice at the study site. Data would be collected from the medical records of such patients prospectively. 
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