To evaluate the effectiveness and safety of ELORES (Ceftriaxone + Sulbactam + Disodium Edetate) in patients with carbapenem resistant gram-negative infections

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. - NIL

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/03/082668

Enrollment

200

Registered

2025-03-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B968- Other specified bacterial agents as the cause of diseases classified elsewhere

Interventions

Intervention1: ELORES (Ceftriaxone + Sulbactam + Disodium Edetate): IV Infusion of ELORES in patients with carbapenem resistant gram-negative infections such as VAP, HAP, cUTI, SSTI, BSI Intervention2

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Effectiveness Endpoints: Clinical cure rate at EOIVT Safety Endpoints: •Incidence of adverse event •Incidence of serious adverse eventTimepoint: As per prescribing information treatment duration will be 5 to 14 days	—

Secondary

Measure	Time frame
28-day mortality Length of Hospital Stay Length of ICU stayTimepoint: Post-study assessment will be conducted on Day 28, as per availability.	—

Countries

India

Contacts

Public ContactRahul Namjoshi

Cipla Ltd

sandesh.sawant3@cipla.com46185000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026