| 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
|
|
|
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
|
|
|
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). |