Upper Respiratory Tract Infections (URTIs) pose a significant public health challenge worldwide. Azithromycin has been approved for its management due to broad-spectrum antibacterial properties and favorable pharmacokinetics. This study aims to evaluate the effectiveness and safety of Azithromycin in treatment of URTIs in a real-world setting. This multicenter, retrospective, observational study was conducted across 184 Ear, Nose, and Throat (ENT) clinics in India. Medical records of adults (≥18 years) who received Azithromycin 500 mg for 5 days to treat URTIs and provided consent were retrieved. Sore throat, fever, and interference with daily activities were assessed alongside clinical signs (pharyngeal erythema, tonsillar erythema, and exudates/plugs on tonsils). Clinical global impression of change was evaluated using a 7-point rating scale. Statistical analyses included paired t-tests for mean score changes and the McNemar-Bowker test to evaluate symptom improvement from baseline to day 5. Data from 884 patients were analyzed. With 5 days of Azithromycin therapy, significant reduction in proportion of patients reporting URTI symptoms and signs was noted. Proportion of patients reporting sore throat was reduced from 95.8% to 10.4%; work absenteeism dropped from 47.9% to 1%; and fever subsided in 97.4% of patients. Clinical signs also improved notably, with moderate-to-severe pharyngeal erythema (90.9% of patients at baseline to 13.6% at day 5), tonsillar erythema (84% ofpatients at baseline to 9.6%), and tonsillar exudates (58.3% patients at baseline to 4.4%). Also, 97.2% of patients showed considerable improvement in their Clinical Global Impression score with Azithromycin. Adverse events were reported by 2.37% of patients. Azithromycin demonstrates a significant improvement in clinical manifestations of URTIs, with a low incidence of adverse events.
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