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).

Venus Remedies Limited0 sites2,500 target enrollmentTBD

ConditionsHealth Condition 1: N10- Acute pyelonephritisHealth Condition 2: M01X- Direct infection of joint in infectious and parasitic diseases classified elsewhereHealth Condition 3: L089- Local infection of the skin and subcutaneous tissue, unspecifiedHealth Condition 4: J150- Pneumonia due to Klebsiella pneumoniaeHealth Condition 5: A415- Sepsis due to other Gram-negativeorganismsHealth Condition 6: H664- Suppurative otitis media, unspecified

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Health Condition 1: N10- Acute pyelonephritisHealth Condition 2: M01X- Direct infection of joint in infectious and parasitic diseases classified elsewhereHealth Condition 3: L089- Local infection of the skin and subcutaneous tissue, unspecifiedHealth Condition 4: J150- Pneumonia due to Klebsiella pneumoniaeHealth Condition 5: A415- Sepsis due to other Gram-negativeorganismsHealth Condition 6: H664- Suppurative otitis media, unspecified
Sponsor: Venus Remedies Limited
Enrollment: 2500
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Pms

Investigators

Sponsor

Venus Remedies Limited

Eligibility 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Not specified

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