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.
Overview
- Phase
- Post Marketing Surveillance
- Status
- Recruiting
- Sponsor
- Cipla Ltd
- Enrollment
- 200
- Locations
- 11
- Primary Endpoint
- Effectiveness Endpoints:
Overview
Brief Summary
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.
Study Design
- Study Type
- Pms
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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
- •Patient is eligible to receive ELORES at least for 5 days at the discretion of the investigator.
- •Patient or their legally acceptable representatives who voluntarily provide written informed consent.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Effectiveness Endpoints:
Time Frame: As per prescribing information treatment duration will be 5 to 14 days
Clinical cure rate at EOIVT
Time Frame: As per prescribing information treatment duration will be 5 to 14 days
Safety Endpoints:
Time Frame: As per prescribing information treatment duration will be 5 to 14 days
• Incidence of adverse event
Time Frame: As per prescribing information treatment duration will be 5 to 14 days
• Incidence of serious adverse event
Time Frame: As per prescribing information treatment duration will be 5 to 14 days
Secondary Outcomes
- 28-day mortality(Length of Hospital Stay)
Investigators
Dr Sandesh Sawant
Cipla Ltd