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Azithromycin in Acute Bacterial Upper Respiratory Tract Infections: An Indian Non-Interventional Study

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Abstract

To assess the effectiveness, safety and tolerability of azithromycin in acute bacterial upper respiratory tract infections (URTIs). In this open-label, prospective, multi-center, non-interventional study in bacterial URTI, the decision to prescribe azithromycin was independent of enrolment. Follow up was 1 week after treatment and if possible, at Week 2. Investigators’ assessment of clinical outcome (Success/Failure) at the end of study was the primary endpoint for efficacy analysis. Clinical outcome of ‘Success’ was defined as the global response of Cure or Improvement. A pharmacoeconomic analysis of management of URTIs was also attempted. Of the 410 patients recruited, all were evaluated for safety and 278 for efficacy. The median treatment duration was 3 days. Following treatment with azithromycin, overall success rate was 98.92% (95% CI 96.88–99.78%; Clopper–Pearson method). The success rate was similar across the sub-groups of acute otitis media—100%, bacterial sinusitis—95.83%, and pharyngotonsillitis—99.38%. The success rate was 100% among children and adolescents (age ≤18 years) and 98.6% among adults (age >18 years). Most of the common signs and symptoms of URTI reported during baseline, significantly improved at the end of the study. Sixteen (3.90%) patients reported treatment emergent adverse events, the most common being diarrhea—5 (1.2%) and flatulence—2 (0.5%). The average cost of treating bacterial URTI was INR 716 per patient. Azithromycin is effective and well tolerated in Indian patients with bacterial URTIs.

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Acknowledgment

This study was funded by Pfizer India. The authors would like to acknowledge and thank R. Bhardwaj MD, S. Bhobe MS (ENT), H. Chehlamkuri MS, B. Choudhary MS (ENT), V. Khalatkar MD, MD, R. Nangia MS, J. Orazem PhD, A. Pasricha MD, C. Potkar MD, R. Bandaru Rao MS, ENT Clinic, S. Raut MPharm, D. Saravanan DORL (ENT), R. Sarma MD, V. Suvarna MD for their contribution.

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  1. Pfizer Limited, Pfizer Centre, Patel Estate, S.V.Road, Jogeshwari (W), Mumbai, 400 102, India

    Shaantanu Donde, Anupam Mishra & Puja Kochhar

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  1. Shaantanu Donde
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  2. Anupam Mishra
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  3. Puja Kochhar
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Correspondence to Shaantanu Donde.

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Donde, S., Mishra, A. & Kochhar, P. Azithromycin in Acute Bacterial Upper Respiratory Tract Infections: An Indian Non-Interventional Study. Indian J Otolaryngol Head Neck Surg 66 (Suppl 1), 225–230 (2014). https://doi.org/10.1007/s12070-011-0437-x

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  • DOI: https://doi.org/10.1007/s12070-011-0437-x

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