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

Not Applicable

Recruiting

Conditions: Pneumonia due to Klebsiella pneumoniae, (2) ICD-10 Condition: N10||Acute pyelonephritis, (3) ICD-10 Condition: A415||Sepsis due to other Gram-negativeorganisms, (4) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, (5) ICD-10 Condition: H664||Suppurative otitis media, unspecified, (6) ICD-10 Condition: M01X||Direct infection of joint in infectious and parasitic diseases classified elsewhere,

Brief Summary: Study Title : - An Observational, Multicenter, Prospective, Post Marketing Surveillance study (P.M.S) to evaluate safety and efficacy of ELORESTM(Ceftriaxone+ Sulbactam+ Disodium Edetate) in patients with various bacterial infections (Labeled indications) Primary Objective : - To obtain safety information on the use of ELORESTM (Ceftriaxone + Sulbactam + Disodium Edetate) in patients with various bacterial infections (Labeled indications). Secondary Objective : - To monitor the therapeutic outcome of ELORESTM (Ceftriaxone + Sulbactam + Disodium Edetate) in subjects with various bacterial infections (Labeled indications). **Primary Endpoints:** Incidence of adverse events (AEs) and incidence of discontinuation due to AEs

**Secondary Endpoints:** Observe of Clinical Cure rate at the end of treatment

Study Design : - An observational multicenter, prospective, post marketing surveillance study Study Duration : - 06 months (or as per sponsorâ€™s discretion)

Recruitment & Eligibility

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.
Planned treatment in line with the Summary of Product Characteristics, i.e. exclusion of all patients with contraindications.

Exclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
To obtain safety information on the use of ELORESTM in patients with various bacterial infections	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).	Observe of Clinical Cure rate at the end of treatment

Locations (17): AMRI Hospital
🇮🇳
Cuttack, ORISSA, India
Apollo Hospital
🇮🇳
Chennai, TAMIL NADU, India
Batra Hospital & Medical Research Centre
🇮🇳
Delhi, DELHI, India
Dayanand Medical College & Hospital
🇮🇳
Ludhiana, PUNJAB, India
Dr. Ram Manohar Lohia Institute of Medical Sciences
🇮🇳
Lucknow, UTTAR PRADESH, India
Ethics Committe for Research Fortis Hospital
🇮🇳
Delhi, DELHI, India
Ethics Committee SMS Medical College & Attached Hospital
🇮🇳
Jaipur, RAJASTHAN, India
Fortis Escorts Heart Institute
🇮🇳
Delhi, DELHI, India
Fortis Hospital
🇮🇳
Chandigarh, CHANDIGARH, India
Institute Ethics Committee All India Institute of Medical Sciences
🇮🇳
Delhi, DELHI, India
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AMRI Hospital
🇮🇳Cuttack, ORISSA, India
Dr Sarat Kumar Behera
Principal investigator
09438554039
drsarat2010@rediffmail.com