Publication:

Clarithromycin 500 mg extended-release in the management of patients with upper respiratory tract infection: results from a prospective, multicentre, single-arm and post-marketing observational study

Background Upper respiratory tract infections (URTI) are a leading cause of morbidity globally and frequently require antibiotic therapy. Clarithromycin extended-release (ER) formulation is widely used for treating URTI, and may improve adherence, gastrointestinal tolerability and outcomes. This study aimed to evaluate the effectiveness and safety of clarithromycin 500 mg ER in Indian patients with URTI.

Methods This prospective, multicenter, single-arm, open-label, post-marketing observational study was conducted at six sites in India. Adults (20-70 years) with acute bacterial URTI (otitis media, sinusitis/pharyngotonsillitis) were enrolled. Patients received clarithromycin 500 mg ER once daily for 7 days, followed by a 5-day telephonic follow-up. Clinical improvement by day 7 (±2), changes in clinical symptom scores (CSS), and safety/tolerability were evaluated.

Results Total of 227 were included in safety analysis set, with a mean (SD) age of 34.35 (11.09) years and a female predominance (129 females, 98 males). By day 7, 82.3% achieved clinical cure and 17.7% showed symptom improvement. Significant mean (SD) CSS reduction of 95.28% (±11.16) was observed (p<0.0001). Curative rates by diagnosis were 88.5% for pharyngotonsillitis, 78.3% for sinusitis, and 66.0% for otitis media. Symptom relief was reported by 76.1% of patients within 3 days. The treatment was well tolerated, and no serious adverse drug reactions (ADRs) were observed.

Conclusions Clarithromycin 500 mg ER demonstrated high effectiveness and tolerability in treatment of URTI in Indian patients. It’s reassuring safety profile and rapid symptom relief support its use in real-world primary care settings.