| CTRI Number |
CTRI/2020/09/028152 [Registered on: 30/09/2020] Trial Registered Prospectively |
| Last Modified On: |
21/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Real world data of patients across India will be retrospectively collected in this study of Levonadifloxacin. |
|
Scientific Title of Study
|
Retrospective, Prescription Event Monitoring (PEM) study of EMROK &/or EMROK – O (Levonadifloxacin) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| WOC/EMR/PEM-01/20, Version 01, Date: 21 May 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vasant Nagvekar |
| Designation |
MBBS, MD (Int Med), FID (Fellowship in Infectious Diseases) American Certified (Tropical Medicine) |
| Affiliation |
ID Clinic |
| Address |
ID Clinic, Department of Physician/Internal Medicine, Infectious diseases, E 1, Ashokraj Ratna Hotel Building, S V Road, Goregaon West
Mumbai
MAHARASHTRA
400104
India |
| Phone |
|
| Fax |
|
| Email |
drnagvekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaishid Ahdal |
| Designation |
Head-Medical Affairs, Medical Affairs Division |
| Affiliation |
Wockhardt Limited |
| Address |
Wockhardt Limited, Department of Medical Affairs, Wockhardt Towers, Bandra Kurla Complex
Mumbai
MAHARASHTRA
400051
India |
| Phone |
9930696711 |
| Fax |
|
| Email |
jahdal@wockhardt.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khokan Debnath |
| Designation |
Head of Clinical Operations, Regulatory Affairs & P V, Medical Affairs |
| Affiliation |
Wockhardt Limited |
| Address |
Wockhardt Limited, Department of Medical Affairs, Wockhardt Towers, Bandra Kurla Complex
Mumbai
MAHARASHTRA
400051
India |
| Phone |
9819644599 |
| Fax |
|
| Email |
KDebnath@wockhardt.com |
|
|
Source of Monetary or Material Support
|
| Wockhardt Limited
Wockhardt Towers, Bandra Kurla Complex
Mumbai – 400 051, India.
|
|
|
Primary Sponsor
|
| Name |
Wockhardt Limited |
| Address |
Wockhardt Towers, Bandra Kurla Complex
Mumbai – 400 051, India.
|
| 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 Vasant Nagvekar |
Dr. Vasant Nagvekar - ID Clinic |
ID Clinic, E 1, Ashokraj Ratna Hotel Building, S V Road, Goregaon West, Mumbai - 400104
Mumbai
MAHARASHTRA |
9820055178
drnagvekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC for Clinical Trials and BA/BE studies), D Y Patil Medical College, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L768||Other intraoperative and postprocedural complications of skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EMROK &/or EMROK – O (Levonadifloxacin) |
- Administer 800 mg every 12 hours by intravenous infusion over a period of
90 minutes for 7-14 days or,
- Following appropriate duration of intravenous therapy, based on physician
discretion, switch over to oral Alalevonadifloxacin mesylate (Emrok O)
1000 mg (two tablets of 500 mg each) every 12 hours. Emrok O tablets to
be swallowed sequentially with sufficient amount of water and may be
taken independent of food. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients who were prescribed with EMROK or EMROK – O by their treating physicians |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of EMROK &/or EMROK – O (Levonadifloxacin) |
At the end of the study by Overall Global Assessment for Efficacy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of EMROK &/or EMROK – O (Levonadifloxacin) |
At the end of the study by Overall Global Assessment for Safety |
|
|
Target Sample Size
|
Total Sample Size="2500"
Sample Size from India="2500"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/10/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Wockhardt has designed this Retrospective, Prescription
Event Monitoring study of EMROK (Levonadifloxacin
Intravenous Injection 800mg/100ml ) & EMROK – O (Levonadifloxacin Tablets 500mg) in real life setting. EMROK and
EMROK - O are indicated in adults with ≥18 years of age. Study end points covered will be: Incidence
rates of adverse events, Improvement rate, Failure rate, Overall Global Assessment for
Efficacy, Overall Global Assessment for
Safety, Patient Demographic
characteristics and Usage of EMROK Treatment. |