An observational and multicentric post marketing surveillance study to evaluate the efficacy and safety of Elores in patients with various bacterial infectio
- 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
- Registration Number
- CTRI/2013/06/003761
- Lead Sponsor
- Venus Remedies Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 2500
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.
No Exclusion criteria in view of Non-Interventional Observational PMS study.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To obtain safety information on the use of ELORESTM in patients with various bacterial infectionsTimepoint: 10 days
- Secondary Outcome Measures
Name Time Method 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