| CTRI Number |
CTRI/2024/09/073689 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prescription Event Monitoring Study of Emrok tab. and Emrok IV to evaluate the safety and efficacy in the patients who have bacterial infections. |
|
Scientific Title of Study
|
A prospective Prescription Event Monitoring (PEM) surveillance to study the safety and efficacy of Emrok (Levonadifloxacin injection) and or Emrok O (Levonadifloxacin Tablet). |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| WOC/EMR/PEM-04/24 Ver. No.01 date 30 Jul.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogesh Kumar Sharma |
| Designation |
Principal Investigator |
| Affiliation |
Aryan clinic Consulting Physician |
| Address |
Aryan Clinic ground floor Kalva Naka Opposite appolo medical Kalva, Thane, Maharashtra
Thane
MAHARASHTRA
400605
India |
| Phone |
9820192129 |
| Fax |
|
| Email |
dryogeshsharmamd@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPurushotham |
| Designation |
Medical Monitor |
| Affiliation |
Wockhardt Ltd |
| Address |
Wockhardt Towers
Bandra-Kurla Complex
Bandra – East, Mumbai
Mumbai
MAHARASHTRA
400 051
India |
| Phone |
9739270420 |
| Fax |
|
| Email |
purushothamVS@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 – East, Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226596407 |
| Fax |
|
| Email |
kdebnath@wockhardt.com |
|
|
Source of Monetary or Material Support
|
| Wockhardt Ltd
Wockhardt Tower BKC Mumbai-400051 |
|
|
Primary Sponsor
|
| Name |
Wockhardt Ltd |
| Address |
Bandra-Kurla Complex
Bandra – East, Mumbai 400051
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Yogesh Kumar Sharma |
Aryan Clinic |
Kalva Naka, opposite appolo Medical Kalva Thane
Thane
MAHARASHTRA |
9820192129
dryogeshsharmamd@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical and Health Research |
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 IV (Levonadifloxacin IV) Emrok Tab (Levonadifloxacin) Oral. |
Emrok (Levonadifloxacin 800mg/100ml) Injection. route of administration: IV will be infused over the period of approx. 90 min.
Emrok Tab 1000 mg BID route of administration Oral. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing to give inform consent.
2. Require Emrok treatment. |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Overall Global Assessment for Safety.
2. Incidence of adverse events.
3.Evaluate the safety profile of EMROK® &/or EMROK O® |
Visit 1,visit 3 and Visit 8 or or as per PI discretion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical Response at early assessment |
Day
3±2 |
| Clinical Success Rate |
At EOT/ day 8±2/PI discretion |
| Microbiological Success Rate |
EOT/ day 8±2 or as per the PI discretion. |
| Overall Global Assessment for Efficacy |
EOT/day 8±2 or as per the PI discretion |
| Usage of EMROK® &/or EMROK O® treatment |
EOT/day 8±2 or as per the PI discretion |
|
|
Target Sample Size
|
Total Sample Size="30000"
Sample Size from India="30000"
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)
|
01/09/2026 |
| 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 will be a prospective and multi-centric prescription event monitoring (PEM)
surveillance in patients who have prescribed with either EMROK® or EMROK O® or
both. Eligible patients will be identified by the investigator / physician based on
inclusion and exclusion criteria. All the patients must have received EMROK® or
EMROK O
® in routine clinical practice at the study site. |