Vol. 7, Issue 1, Part A (2025)

Background: Amoxicillin-clavulanate combinations are widely prescribed for respiratory tract infections, but real-world tolerability and clinical outcomes data in Indian populations remain limited. Rising β-lactamase-producing bacterial resistance necessitates evaluation of these fixed-dose combinations in routine clinical practice. Objectives: The primary objective was to assess the tolerability of Ampilox-CV (amoxicillin 500 mg and clavulanic acid 125 mg) in patients with various bacterial infections. The secondary objective was to describe clinical outcomes in patients treated for community-acquired pneumonia (CAP) and acute bacterial sinusitis (ABS). Methods: This retrospective, multicentric, observational study analysed medical records from 155 sites across India between 04 Nov 2024 to 25 Mar 2025. Adult patients (18-65 years) diagnosed with CAP, ABS, or other bacterial infections who completed 7-14-days Ampilox-CV treatment courses were included. Data on demographics, adverse events (AEs), physician-reported tolerability ratings, and clinical response were collected and analysed descriptively. Results: A total of 1,027 patients (mean age 39.8±11.7 years) were analysed. The most frequent diagnoses were ABS (57.9%) and CAP (18.7%); 23.4% had other bacterial infections. Most patients (91.3%) received Ampilox-CV three times daily. Adverse events were reported in 101 patients (9.8%), predominantly gastrointestinal (diarrhoea, nausea). Most AEs were mild (31.7%) or moderate (62.4%), with complete resolution in 97.0% of cases. Physician-assessed tolerability was rated as excellent in 92.6% and very good in 7.3% of patients. Clinical response was rated as excellent in 88.7% and very good in 10.8% of cases, though these outcomes lack objective validation and control group comparison. Conclusion: Ampilox-CV demonstrated acceptable tolerability in routine clinical practice across diverse bacterial infections, with low rates of treatment-discontinuing adverse events. While physician-reported clinical responses were favourable, the single-arm retrospective design precludes definitive conclusions about comparative effectiveness. These descriptive findings provide real-world safety data that may inform clinical decision-making, but controlled comparative studies are needed to establish therapeutic efficacy.