| CTRI Number |
CTRI/2025/03/082668 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the effectiveness and safety of ELORES (Ceftriaxone + Sulbactam + Disodium Edetate) in patients with carbapenem resistant gram-negative infections |
|
Scientific Title of Study
|
A prospective, observational, multi-center real world study to evaluate the effectiveness and safety of ELORES (Ceftriaxone plus Sulbactam plus Disodium Edetate) in patients with carbapenem resistant gram-negative infections caused by Enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae) and Acinetobacter baumannii. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CP/04/24, Version no.01, dated 04/12/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandesh Sawant |
| Designation |
Head Clinical Trials |
| Affiliation |
Cipla Ltd |
| Address |
Cipla Ltd, 289 Bellasis Road, Mumbai Central
Mumbai
MAHARASHTRA
400008
India |
| Phone |
46185000 |
| Fax |
|
| Email |
sandesh.sawant3@cipla.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandesh Sawant |
| Designation |
Head Clinical Trials |
| Affiliation |
Cipla Ltd |
| Address |
Cipla Ltd, 289 Bellasis Road, Mumbai Central
Mumbai
MAHARASHTRA
400008
India |
| Phone |
46185000 |
| Fax |
|
| Email |
sandesh.sawant3@cipla.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahul Namjoshi |
| Designation |
Senior Manager Clinical Research Division |
| Affiliation |
Cipla Ltd |
| Address |
Cipla Ltd, 289 Bellasis Road, Mumbai Central
Mumbai
MAHARASHTRA
400008
India |
| Phone |
46185000 |
| Fax |
|
| Email |
rahul.namjoshi@cipla.com |
|
|
Source of Monetary or Material Support
|
| Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam
Marg, Lower Parel, Mumbai – 400013, India |
|
|
Primary Sponsor
|
| Name |
Cipla Ltd |
| Address |
Cipla Ltd, 289 Bellasis Road, Mumbai Central, Mumbai, Maharashtra, 400008, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Senthur Nambi |
Apollo Hospitals |
Apollo Hospital, No. 21, Greams Road, Greams Lane off, Chennai, Tamil Nadu - 600006
Chennai
TAMIL NADU |
9841495288
senthurnambi@gmail.com |
| Dr C Ayyapan |
Apollo Specialty Hospital |
Anaesthesiology & Critical Care, Lake View Road, K K Nagar, Madurai - 625020
Madurai
TAMIL NADU |
9894696456
Ayyappan.ibu@gmail.com |
| Dr Rajesh Pande |
BLK MAX Super Speciality Hospital |
Pusa Road New Delhi India 110005
New Delhi
DELHI |
9810536268
rajeshmaitree2000@gmail.com |
| Dr Komal Jasani |
Dr. Vasantrao Pawar Medical College Hospital & Research Center |
Vasantdada Nagar, Adgaon, Nashik - 422003
Nashik
MAHARASHTRA |
8156060999
komaljasani@yahoo.com |
| Dr Chandani Bhagat |
Institute of Liver & Biliary Sciences |
Nephrology Department, D-1, Vasant Kunj, New Delhi
South West
DELHI |
9599474692
chandani.bhagat@gmail.com |
| Dr Anil Gurnani |
Kailash Hospital and Heart Institute |
Anaesthesia & Critical Care, H-33, Sector 27, Noida, UP - 201301
Gautam Buddha Nagar
UTTAR PRADESH |
9811017238
icuanilgurnani@gmail.com |
| Dr Harjit Dumra |
KD Hospital |
Critical Care Medicine, Near Vaishnodevi Circle, SG Highway, Ahmedabad - 382421
Ahmadabad
GUJARAT |
9825023160
drdumra@yahoo.co.in |
| Dr Subhash Todi |
Manipal Hospitals (East) India Private Limited |
Critical Care Medicine, P 4 and 5, CIT Scheme, Block A, Gariahat Road, Kolkata - 700029
Kolkata
WEST BENGAL |
9831202040
drsubhashtodi@gmail.com |
| Dr Yatin Mehta |
Medanta The Medicity Hospital |
Sector 38 Gurgaon Haryana 122001
Gurgaon
HARYANA |
9971698149
yatinmehta@hotmail.com |
| Dr Ashwini Tayade |
Wockhardt Hospitals |
Infectious Diseases department, 1634, North Ambazari Road, Nagpur - 440010
Nagpur
MAHARASHTRA |
8408871177
drashwini.tayade@gmail.com |
| Dr Brijesh Prajapat |
Yashoda Hospital and Research Centre |
Pulmonary & Critical Care Medicine, IIIrd M, Nehru Nagar, Ghaziabad - 201001
Ghaziabad
UTTAR PRADESH |
8607731947
dr.brijeshprajapat@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Clinimed Independent Ethics Committee |
Approved |
| Ethics Committee / AARCE, BLK MAX |
Approved |
| ILBS Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Apollo Hospitals |
Approved |
| Institutional Ethics committee Dr Vasantrao Pawar Medical College Hospital and Research Center |
Approved |
| Institutional Ethics Committee, Apollo Hospitals, Madurai |
Approved |
| Institutional Ethics Committee, Wokhardt Hospital Nagpur |
Approved |
| Kailash Ethics Committee |
Approved |
| KD Hospital Institutional Ethics Committee |
Approved |
| Medanta Institutional Ethics Committee |
Approved |
| Yashoda hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ELORES containing Ceftriaxone and Sulbactam and Disodium Edetate |
Intravenous Administration of 1.5 g to 3 g every 24 hours or in two divided doses which could be increased as per severity of infection (in severe septicemic cases) to a maximum dosage of 6 g per day in divided doses |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All adult patients (more than or equal to 18 years of age) with carbapenem resistant gram-negative infections (suspected or proven) such as ventilator associated pneumonia (VAP), hospital acquired pneumonia (HAP), complicated urinary tract infection (cUTI), skin and soft tissue infection (SSTI) bloodstream infection (BSI) and eligible to receive ELORES as per prescribing information at discretion of Investigator
2. Patient is eligible to receive ELORES at least for 5 days at the discretion of the investigator.
3. Patient or their legally acceptable representatives who voluntarily provide written informed consent |
|
| ExclusionCriteria |
| Details |
1. Hypersensitivity to ceftriaxone or salbactum or disodium edetate or their excipients or drugs used in the study or any beta lactam antibiotic
2.Patients receiving intravenous calcium treatment
3.Pregnant or breastfeeding women
4.Renal insufficiency with creatinine clearance less than 30 mL per hr. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effectiveness Endpoints:
Clinical cure rate at EOIVT
Safety Endpoints:
• Incidence of adverse event
• Incidence of serious adverse event |
As per prescribing information treatment duration will be 5 to 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
28-day mortality
Length of Hospital Stay
Length of ICU stay |
Post-study assessment will be conducted on Day 28, as per availability. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
31/03/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a prospective, observational, multi-center real world study to evaluate the effectiveness and safety of ELORES (Ceftriaxone + Sulbactam + Disodium Edetate) in patients with carbapenem resistant gram-negative infections caused by Enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae) and Acinetobacter baumannii. |