| CTRI Number |
CTRI/2013/06/003761 [Registered on: 17/06/2013] Trial Registered Retrospectively |
| Last Modified On: |
18/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational and multicentric post marketing surveillance study to evaluate the efficacy and safety of Elores in patients with various bacterial infection |
|
Scientific Title of Study
|
An Observational, Multicentre, Prospective, Post Marketing Surveillance study to evaluate safety and efficacy of ELORESTM (Ceftriaxone, Sulbactam and Disodium Edetate) in patients with various bacterial infections (Labeled indications). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yatin Mehta |
| Designation |
Chairman |
| Affiliation |
Institute of Critical Care and Anaesthesia |
| Address |
Medanta- The Medicity,
Institute of Critical Care and Anaesthesia
Sector - 38, Gurgaon
Haryana 122001, India
Gurgaon
HARYANA
122001
India |
| Phone |
0124-4834469 |
| Fax |
|
| Email |
Yatin.mehta@medanta.org |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Mohd Amin Mir |
| Designation |
Director |
| Affiliation |
Venus Remedies Limited |
| Address |
Venus Medicine Research Center, Venus Remedies Limited, Hill Top Industrial Estate, Jharmajri EPIP Phase-1 Extension Bhatoli Kalan, Baddi, Himachal Pradesh India
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
01795302051 |
| Fax |
01795271272 |
| Email |
drmir@vmrcindia.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Mohd Amin Mir |
| Designation |
Director |
| Affiliation |
Venus Remedies Limited |
| Address |
Venus Medicine Research Centre, Venus Remedies Limited, Hill Top Industrial Estate, Jharmajri EPIP Phase-1 Extension Bhatoli Kalan, Baddi, Himachal Pradesh India
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
01795302051 |
| Fax |
01795271272 |
| Email |
drmir@vmrcindia.com |
|
|
Source of Monetary or Material Support
|
| Venus Remedies Limited Hill Top Industrial Estate Near Jharmajri, E.P.I.P., Phase-I, (Extention) Village Bhatoli Kalan Baddi, Himachal Pradesh Pin code: 173 205, India |
|
|
Primary Sponsor
|
| Name |
Venus Remedies Limited |
| Address |
Plot No-51-52 Industrial Area Phase-1 Panchkula -134113 Haryana (India) |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 17 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sarat Kumar Behera |
AMRI Hospital |
Pulmonology and Critical Care Department
Plot No. 1, Near Jayadev Vatika, Khandagiri, Bhubaneswar, Odisha-751030
Cuttack
ORISSA |
09438554039
drsarat2010@rediffmail.com |
| Dr V Ramasubramanian |
Apollo Hospital |
Senior consultant, Infectious Disease, 21, Greams Lane, off Greams road
Chennai, 600006
Chennai
TAMIL NADU |
9840078979
idisdoc@gmail.com |
| Dr S S Arora |
Batra Hospital & Medical Research Centre |
1 Tughlakabad Institutional Area, Mehrauli Badarpur Road
New Delhi- 110062 (India)
New Delhi
DELHI |
9810113414
drssarora@gmail.com |
| Dr Amit Bery |
Dayanand Medical College & Hospital |
Medicine department
Tagore Nagar, Civil Lines, Near Rose Garden,
Ludhiana, Punjab -141001
Ludhiana
PUNJAB |
9876080057
amitbery@yahoo.co.in |
| Dr Prof Deepak Malviya |
Dr. Ram Manohar Lohia Institute of Medical Sciences |
Vibhuti Khand, Gomti Nagar,
Lucknow, Uttar Pradesh 226010
Lucknow
UTTAR PRADESH |
8176007063
drdm58@gmail.com |
| Dr Vivek Nangia |
Ethics Committe for Research Fortis Hospital |
Fortis Flt. Lt. Ranjan Dhall Hospital, Sector B, Pocket 1, Aruna Asaf Ali Marg, Vasant Kunj, New Delhi - 110070
New Delhi
DELHI |
9810048885
01142776221
viveknangia@gmail.com |
| Dr C L Nawal |
Ethics Committee SMS Medical College & Attached Hospital |
SMS Medical College & Attached Hospital, Jaipur
Jaipur
RAJASTHAN |
09414044005
drclnawal@gmail.com |
| Dr Avi Kumar |
Fortis Escorts Heart Institute |
Department of Pulmonology
New Delhi
DELHI |
9811946525
avi.kumar@fortishealthcare.com |
| Dr Vishal Bhambri |
Fortis Hospital |
Sector - 62, Phase - VIII, Mohali - 160062
Chandigarh
CHANDIGARH |
09814338766
911724692221
vishal.bhambri@fortishealthcare.com |
| Dr Randeep Guleria |
Institute Ethics Committee All India Institute of Medical Sciences |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
Room No 102, 1 st Floor Old O. T. Block, ANSARI NAGAR, NEW DELHI 110029
New Delhi
DELHI |
01126593676
randeepg@hotmail.com |
| Dr Tanu Singhal |
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute |
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute,
Rao saheb Achutrao Patwardhan Marg, Four bungalows, Andheri west, Mumbai 400 053
Mumbai
MAHARASHTRA |
9320211770
tanusinghal@yahoo.com |
| Dr B K Agarwal |
M. M. Institute of Medical Sciences and Research |
Dean Academic
Department of Medicine
Mullana, Ambala, Haryana, India Pin-133203
Ambala
HARYANA |
8059931341
onlybimal@gmail.com |
| Dr Ranjana Chhabra |
Max Super speciality Hospital |
Max Super speciality Hospital(A Unit of Balaji Medical & Diagnostic Research Centre),
108-A, Indraprastha Ext., Patparganj, New Delhi-110092
New Delhi
DELHI |
01143033333
01143170823
ranjana.chhabra@maxhealthcare.com |
| Dr Yatin Mehta |
Medanta The Medicity |
Medanta- The Medicity, Institute of Critical Care and Anaesthesia Sector - 38, Gurgaon Haryana 122001, India
Gurgaon
HARYANA |
01244834469
Yatin.mehta@medanta.org |
| Dr Ravimohan S Mavuduru |
Postgraduate Institute of Medical Education & Research |
Department of Urology
PGIMER, Sector-12, Chandigarh PIN- 160012
Chandigarh
CHANDIGARH |
9417532955
ravismi2003@yahoo.com |
| Dr Prachee Sathe |
Ruby Hall Clinic |
Ruby Hall Clinic
Department of Critical Care Medicine, Ruby Hall clinic, Grant Medical Foundation, 40, Sassoon Road, Pune, Maharshtra-411001
Pune
MAHARASHTRA |
9960686867
prachee.sathe@gmail.com |
| Dr Parvaiz Koul |
Sher-i-Kashmir Institute of Medical Sciences |
Department of Pulmonary
Kashmir, Soura, Srinagar 190011, J&K (India)
Srinagar
JAMMU & KASHMIR |
9419004822
parvaizk@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 16 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Fortis Hospital |
Approved |
| Institutional Ethics Committee SMS Medical College & AttachedHospitals |
Approved |
| Drug Trial Ethics Committee |
Approved |
| Ethics Committee For Research Fortis Hospital |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Approved |
| Institutional Ethics committee Dr. Ram Manohar Lohia Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee M M Institute of Medical Sciences and Research |
Approved |
| Institutional Ethics Committee Poona Medical Research Foundation |
Approved |
| Institutional Ethics Committee, Bhubaneswar |
Approved |
| Institutional Ethics Committee, FEHI |
Approved |
| Institutional Ethics Committee-Clinical Studies |
Approved |
| Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute |
Approved |
| Max Superspeciality Hospital |
Approved |
| Medanta the Medicity |
Approved |
| Scientific Research & Ethical Review Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J150||Pneumonia due to Klebsiella pneumoniae, (2) ICD-10 Condition: N10||Acute pyelonephritis, (3) ICD-10 Condition: A415||Sepsis due to other Gram-negativeorganisms, (4) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, (5) ICD-10 Condition: H664||Suppurative otitis media, unspecified, (6) ICD-10 Condition: M01X||Direct infection of joint in infectious and parasitic diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ELORES |
1.5 gm, IV, BD, 5-10 days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
Inclusion Criteria
Modification(s)
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Eligibility Criteria:
1. Patients with a suspected or confirmed diagnosis of bacterial infection (labelled indications)
2. Patients who receive a prescription of ELORES according to the indication stated in the local
approved SmPC [Lower Respiratory Tract Infections, Urinary Tract Infections (complicated and
uncomplicated), Bacterial Septicaemia, Chronic Suppurative Otitis Media, Infections of Bones
and Joints, Infections of Skin and Soft Tissues, Surgical Prophylaxis (including pre and postsurgical
infections)]
3. Written informed consent signed by the patient or legally acceptable representative(s) in line
with applicable regulation of country.
4. Planned treatment in line with the Summary of Product Characteristics, i.e. exclusion of all
patients with contraindications. |
|
| ExclusionCriteria |
| Details |
No Exclusion criteria in view of Non-Interventional Observational PMS study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To obtain safety information on the use of ELORESTM in patients with various bacterial infections |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the therapeutic outcome of ELORESTM (Ceftriaxone + Sulbactam + Disodium Edetate) in subjects with various bacterial infections (Labeled indications). |
Observe of Clinical Cure rate at the end of treatment |
|
|
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)
|
03/07/2013 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study Title : - An Observational, Multicenter, Prospective, Post Marketing Surveillance study (P.M.S) to evaluate safety and efficacy of ELORESTM(Ceftriaxone+ Sulbactam+ Disodium Edetate) in patients with various bacterial infections (Labeled indications)
Primary Objective : - To obtain safety information on the use of ELORESTM (Ceftriaxone + Sulbactam + Disodium Edetate) in patients with various bacterial infections (Labeled indications).
Secondary Objective : - To monitor the therapeutic outcome of ELORESTM (Ceftriaxone + Sulbactam + Disodium Edetate) in subjects with various bacterial infections (Labeled indications).
Primary Endpoints: Incidence of adverse events (AEs) and incidence of discontinuation due to AEs Secondary Endpoints: Observe of Clinical Cure rate at the end of treatment
Study Design : - An observational multicenter, prospective, post marketing surveillance study
Study Duration : - 06 months (or as per sponsor’s discretion)
|