An observational and multicentric post marketing surveillance study to evaluate the efficacy and safety of Elores in patients with various bacterial infection

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).

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2013/06/003761

Enrollment

2500

Registered

2013-06-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: N10- Acute pyelonephritis Health Condition 2: M01X- Direct infection of joint in infectious and parasitic diseases classified elsewhere Health Condition 3: L089- Local infection of the skin and subcutaneous tissue, unspecified Health Condition 4: J150- Pneumonia due to Klebsiella pneumoniae Health Condition 5: A415- Sepsis due to other Gram-negativeorganisms Health Condition 6: H664- Suppurative otitis media, unspecified

Interventions

Intervention1: ELORES: 1.5 gm, IV, BD, 5-10 days Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: No Exclusion criteria in view of Non-Interventional Observational PMS study.

Design outcomes

Primary

Measure	Time frame
To obtain safety information on the use of ELORESTM in patients with various bacterial infectionsTimepoint: 10 days	—

Secondary

Measure	Time frame
To monitor the therapeutic outcome of ELORESTM (Ceftriaxone + Sulbactam + Disodium Edetate) in subjects with various bacterial infections (Labeled indications).Timepoint: Observe of Clinical Cure rate at the end of treatment	—

Countries

India

Contacts

Public ContactDr Mohd Amin Mir

Venus Remedies Limited

drmir@vmrcindia.com01795302051

Outcome results

None listed

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