| CTRI Number |
CTRI/2021/08/035789 [Registered on: 18/08/2021] Trial Registered Prospectively |
| Last Modified On: |
17/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prescription Event Monitoring |
| Study Design |
Other |
|
Public Title of Study
|
Prescription Event Monitoring (PEM) for EMROK tablet and Injections |
|
Scientific Title of Study
|
Prospective, Prescription Event Monitoring (PEM) surveillance of EMROK® (Levonadifloxacin injection) &/or EMROK – O® (Levonadifloxacin tablet) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjith Saseesharan |
| Designation |
Consultant Physician-Critical Care Medicine |
| Affiliation |
S L Raheja |
| Address |
S. L. Raheja Hospital, Raheja Hospital Marg, Mahim West, Mahim, Mumbai, Maharashtra 400016
Mumbai
MAHARASHTRA
400016
India |
| Phone |
9004479549 |
| Fax |
|
| Email |
docsanjith@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kapil Dev Mehta |
| Designation |
Head-Medical Affairs |
| Affiliation |
Wockhardt Ltd. |
| Address |
Wockhardt Limited Wockhardt Towers Bandra Kurla Complex
Mumbai - 400051 Mumbai MAHARASHTRA 400051 India
Mumbai (Suburban)
MAHARASHTRA
400051
India
Mumbai (Suburban)
MAHARASHTRA
400051
India |
| Phone |
022-26596742 |
| Fax |
|
| Email |
kapilm@wockhardt.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khokan Debnath |
| Designation |
Head of Clinical Operations, Regulatory Affairs & Pharmacovigilance (India & Emerging market) |
| Affiliation |
Wockhardt Ltd. |
| Address |
Wockhardt Limited Wockhardt Towers Bandra Kurla Complex
Mumbai - 400051 Mumbai MAHARASHTRA 400051 India
Mumbai (Suburban)
MAHARASHTRA
400051
India
Mumbai (Suburban)
MAHARASHTRA
400051
India |
| Phone |
022-26596765 |
| Fax |
|
| Email |
kdebnath@wockhardt.com |
|
|
Source of Monetary or Material Support
|
| Wockhardt Ltd. Wockhardt Towers Bandra Kurla Complex 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 Sanjith Saseedharan |
S L Raheja Hospital |
Raheja Hospital Marg, Mahim West, Mahim, Mumbai, Maharashtra 400016
Mumbai
MAHARASHTRA |
9004479549
docsanjith@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DY Patil Medical College Hospital & Research Centre |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of any gender who have been prescribed with EMROK® or EMROK – O® by their treating physicians can be part of this prescription event monitoring surveillance |
|
| ExclusionCriteria |
| Details |
1. Known to be hypersensitive to Levonadifloxacin and any other quinolone antibactrial or to any other excepients
2. Patients having history of Tendon disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate safety and efficacy of EMROK® (Levonadifloxacin injection) &/or EMROK – O® (Levonadifloxacin tablet) in real world setting |
Day 1, Day 3 and Day 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical Success rate
Microbiological Success rate
Overall Global Assessment for Efficacy
Overall Global Assessment for Safety
Usage of EMROK Treatment
Incidence of Adverse events
|
Day 1
Day 3 and
Day 8 |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/08/2021 |
| 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
|
Publication will be done after study report completion |
|
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 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 improvement or failure with respect to changes in the symptoms of infection pre and post EMROK therapy. 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. |