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

Samir Bhargava; Digvijay Singh Rawat; Mubarak M. Khan; M. B. Bharathi; M. Ilambarathi; Dhrubo Roy; Amrutha H. R.; Asif Shaikh; Shivani Acharya; Rhutuja Rane

doi:10.18203/issn.2454-5929.ijohns20253387

Authors

Samir Bhargava Bhargava Nursing Home, Gopal Bhuvan, Mumbai, Maharashtra, India
Digvijay Singh Rawat Department of ENT, Jawaharlal Nehru Medical College, Ajmer, Rajasthan, India
Mubarak M. Khan Sushrut ENT Hospital and Dr Khan's Research Center, Talegaon Dabhade, Pune, Maharashtra, India
M. B. Bharathi Department of ENT, JSS Hospital, Mysore, Karnataka, India
M. Ilambarathi IGENT-ENT Day Care Center, Nanganallur, Chennai, Tamil Nadu, India
Dhrubo Roy Department of ENT, Manipal Hospital, Kolkata, West Bengal, India
Amrutha H. R. Department of ENT, JSS Hospital, Mysore, Karnataka, India
Asif Shaikh Department of Medical Affairs, Abbott Healthcare Private Limited, Bandra (E) Mumbai, Maharashtra, India
Shivani Acharya Department of Medical Affairs, Abbott Healthcare Private Limited, Bandra (E) Mumbai, Maharashtra, India
Rhutuja Rane Department of Medical Affairs, Abbott Healthcare Private Limited, Bandra (E) Mumbai, Maharashtra, India

DOI:

https://doi.org/10.18203/issn.2454-5929.ijohns20253387

Keywords:

Clarithromycin, Upper respiratory tract infection, Acute otitis media, Acute pharyngotonsillitis, Acute bacterial sinusitis

Abstract

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.

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