A Randomized, Open label, Multicentre, Parallel group, Active-Controlled Comparative Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of Amoxycillin and Potassium Clavulanate Oral Dispersible Tablet (600 mg/42.9 mg) for the Treatment of Bacterial infections Compared to Amoxycillin 400mg Dispersible Tablet in Indian Patients.

This is a randomized, open-label, multicentre, parallel-group, active-controlled Phase 3 trial to be conducted across multiple sites in India after obtaining regulatory and Ethics Committee approvals. Following informed consent, patients will undergo screening (up to 3 days), and the total study duration will be 14 days. Eligible patients will be randomized 1:1 to receive either amoxicillin–clavulanate or amoxicillin alone for 7–10 days. The study includes four visits: screening, baseline/enrolment, end of treatment, and follow-up. Non-responders will continue treatment with add-on therapy; their safety data will be included in safety and ITT analyses, though their efficacy data will be excluded from the primary efficacy analysis. Safety and efficacy assessments will be conducted throughout the study as per the schedule of assessments.