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CTRI Number  CTRI/2023/09/057485 [Registered on: 12/09/2023] Trial Registered Prospectively
Last Modified On: 11/09/2023
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   To evaluate the safety and efficacy of Emrok tablet and Emrok Injection by the surveillance study. 
Scientific Title of Study   A Prospective Prescription Event Monitoring PEM surveillance of EMROK Levonadifloxacin injection and or EMROK O Levonadifloxacin tablet. 
Trial Acronym  Emrok PEM 2023 
Secondary IDs if Any  
Secondary ID  Identifier 
WOC/EMR/PEM-09/23 ver.01 Date 25 May 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hemant Thacker 
Designation  Director and Head of department of medicine at Bhatia Hospital 
Affiliation  Bhatia Hospital 
Address  Bhatia Hospital, G-1 Block (Ground Floor), Tukaram Javji Road, Tardeo, Mumbai 400007

Mumbai
MAHARASHTRA
400007
India 
Phone  9820073882  
Fax    
Email  dochpt@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Khokan Debnath 
Designation  Senior General Manager (Head) – RA, Clinical Operations, PV and QA (India and Emerging Market) 
Affiliation  Wockhardt Ltd. 
Address  Wockhardt Towers Bandra Kurla Complex Bandra – 400 051 Mumbai MAHARASHTRA 400051 India Mumbai MAHARASHTRA 400 051 India

Mumbai
MAHARASHTRA
400051
India 
Phone  02226596447  
Fax    
Email  kdebnath@wockhardt.com  
 
Details of Contact Person
Public Query
 
Name  Dr Khokan Debnath 
Designation  Senior General Manager (Head) – RA, Clinical Operations, PV and QA (India and Emerging Market) 
Affiliation  Wockhardt Ltd. 
Address  Wockhardt Towers Bandra Kurla Complex Bandra – 400 051 Mumbai MAHARASHTRA 400051 India Mumbai MAHARASHTRA 400 051 India

Mumbai
MAHARASHTRA
400051
India 
Phone  02226596407  
Fax    
Email  kdebnath@wockhardt.com  
 
Source of Monetary or Material Support  
Wockhardt Ltd. Wockhardt Towers, Bandra – Kurla Complex, Bandra East, Mumbai 400051 
 
Primary Sponsor  
Name  Wockhardt Ltd 
Address  Wockhardt Towers Bandra Kurla Complex 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 Hemant Thacker  Bhatia Hospital  Department of medicine, G-1 Block, Ground Floor, Bhatia Hospital, Tukaram Javji Road, Tardeo, Mumbai 400007
Mumbai
MAHARASHTRA 
9820073882

dochpt@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: A488||Other specified bacterial diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Emrok Injection (Levonadifloxacin 800mg/100ml).   Emrok (Levonadifloxacin 800mg/100ml) Injection. route of administration: IV will be infused over the period of approx. 90 min. Study duration 5-14 days. 
Intervention  Emrok-O tablet (Levonadifloxacin tablet 500 mg)   1000 mg BID route of administration Oral. study duration 5-14 days. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult (at least 18 years of age) patient of any gender prescribed with EMROK or/and EMROK-O and willing to provide written informed consent to share information 
 
ExclusionCriteria 
Details  1. Known to be hypersensitive to Levonadifloxacin and any other quinolone antibactrial or to any other excepients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical success rate will be assessed by Resolution of signs and symptoms without the need for additional antimicrobial agents
 
at 2 weeks.
 
 
Secondary Outcome  
Outcome  TimePoints 
Microbiological Success: absence of pathogen
 
at 2 weeks 
Overall Global Assessment for Efficacy:Investigator will evaluate global assessment for efficacy based on 5-point Likert scale of excellent, very good, good, satisfactory & poor  2 weeks 
Overall Global Assessment for Safety: Investigator will evaluate global assessment for safety based on 5-point Likert scale of excellent, very good, good, satisfactory & poor  at 2 weeks 
 
Target Sample Size   Total Sample Size="2500"
Sample Size from India="2500" 
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)   19/09/2023 
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="0"
Months="5"
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 EMROK® or EMROK-O® or both. Eligible patients will be identified by the investigator / physician based on selection criteria. All the patients must have received EMROK® or EMROK–O® in routine clinical practice at the study site. Data would be collected from the medical records of such patients prospectively. After identification of patients for this PEM, prescribing investigator would record patient’s demographics, physical examination, Medical history and Concomitant medication, Prescribing indication and regimen for EMROK® or EMROK–O®, adverse events associated with use of EMROK® or EMROK-O® in case record form. .
Safety assessment would be done on the basis of adverse event encountered by the patients during the usage of EMROK® and / or EMROK - O®. Efficacy would be determined by the investigator in terms of success, cure, improvement or failure with respect to changes in the symptoms of infection pre and post EMROK therapy changes
Investigator will perform global assessment for efficacy and safety of EMROK® and / or EMROK – O® at the end of study period on 5 point scale. The investigator shall provide the declaration for accuracy of the data. The observation period would be the earliest of any of following event viz. End of therapy / Lost to follow-up / Clinical success / Clinical failure. The relevant data would be updated in the case record form.
Day 1 of Treatment initiation
Patients who have been prescribed with EMROK® or EMROK – O® by their treating physicians will be identified for the study. Written informed consent will be obtained from eligible patients to share information and medical records during observation period of surveillance. Demographics, physical examination, medical history, concomitant medication, clinical assessment of signs and symptoms, microbiological assessment including culture report, prescribing pattern including but not limited to indication, dose, frequency, duration of EMROK® or EMROK – O® will be recorded in case report form.
Follow up 1 for data collection; Early Assessment (Day 3 ± 2 of treatment initiation) Patient will be followed up for early assessment of EMROK treatment initiation. Finding of clinical assessment, microbiological assessment, culture report, concomitant medications, adverse event, if any will be recorded in case report form.
Follow up 2 for data collection; End of Therapy (EOT) (Day 7±2 Onwards until 15 days of treatment initiation or EOT)
Patient will be followed up at end of therapy. Finding of clinical assessment, concomitant medications, adverse event, if any and microbiological assessment as per availability will be recorded in case report form. Investigator will assess overall effectiveness and safety based on 5 point scale (Excellent, Very good, Good, Satisfactory and Poor).
 
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