Clinical effectiveness of co-amoxiclav in upper respiratory tract infections: results from a large multicenter real-world evidence study

Akash Saha; Pushpak Palod; Vaibhav Lamdhade; Vinay Bagaria; Ajitkumar Gondane; Amitrajit Pal; Dattatray Pawar; Akhilesh Sharma

doi:10.18203/2349-3933.ijam20263710

Authors

Akash Saha Department of ENT and HNS, BC Roy Post-graduate institute of Pediatric sciences, Kolkata, West Bengal, India
Pushpak Palod SSNK Medical College, Kopargaon, Ahmednagar, Maharashtra, India
Vaibhav Lamdhade Shobha, Hospital, Jalgaon, Maharashtra, India
Vinay Bagaria Medical Affairs Team, Alkem Laboratories, Mumbai, Maharashtra, India
Ajitkumar Gondane Medical Affairs Team, Alkem Laboratories, Mumbai, Maharashtra, India
Amitrajit Pal Medical Affairs Team, Alkem Laboratories, Mumbai, Maharashtra, India
Dattatray Pawar Medical Affairs Team, Alkem Laboratories, Mumbai, Maharashtra, India
Akhilesh Sharma Medical Division, Alkem Laboratories Ltd Mumbai, India

DOI:

https://doi.org/10.18203/2349-3933.ijam20263710

Keywords:

Antimicrobial stewardship, Antibiotic prescribing patterns, Respiratory bacterial infections, Treatment outcomes

Abstract

Background: Upper respiratory tract infections (URTIs) are among the most common reasons for outpatient consultations and antibiotic prescribing. Although many URTIs are viral, bacterial infections and secondary bacterial complications often require antimicrobial treatment. Co-amoxiclav is widely used for bacterial respiratory infections; however, large-scale real-world evidence (RWE) remains limited. This study evaluated the effectiveness and prescribing patterns of co-amoxiclav in routine clinical practice.

Methods: This multicenter, retrospective, medical record-based RWE study included patients with URTIs who received co-amoxiclav across participating centers. Demographic characteristics, prescribing patterns, and treatment outcomes were evaluated in pediatric (≤12 years) and adult (>12 years) populations. Clinical outcomes were categorized as cure, improvement, or no improvement.

Results: A total of 12,986 patients were included, comprising 1,116 pediatric and 11,870 adult patients. Unspecified URTI was the predominant diagnosis (81.6%), followed by tonsillitis, acute otitis media (AOM), pharyngitis, sinusitis, and laryngitis. Suspension formulations were prescribed more frequently in pediatric patients, whereas tablet formulations predominated among adults. Twice-daily dosing was the most commonly prescribed regimen across age groups. Overall clinical success (cure plus improvement) was achieved in 12,970 patients (99.88%). Complete clinical cure was documented in 12,295 patients (94.7%), while 675 patients (5.2%) showed clinical improvement and only 16 patients (0.1%) reported no improvement. Clinical cure rates were comparable between pediatric and adult populations (93.8% vs. 94.8%, respectively).

Conclusions: Co-amoxiclav demonstrated high rates of clinical cure and overall treatment success in patients with URTIs across pediatric and adult populations, supporting its effectiveness in routine clinical practice when appropriately prescribed for suspected bacterial respiratory infections.

References

Eccles R. Understanding the symptoms of the common cold and influenza. Lancet Infect Dis. 2005;5(11):718-25.

Cherry JD. The common cold. In: Feigin and Cherry's Textbook of Pediatric Infectious Diseases. 8th ed. Philadelphia: Elsevier. 2019.

Brook I. Microbiology and management of respiratory tract infections in children. J Fam Pract. 2003;52(12):S8-15.

Feldman C, Anderson R. Recent advances in the epidemiology and prevention of Streptococcus pneumoniae infections. F1000Res. 2020;9:F1000.

Chow AW, Benninger MS, Brook I, Brozek JL, Goldstein EJ, Hicks LA, et al. IDSA clinical practice guideline for acute bacterial rhinosinusitis in children and adults. Clin Infect Dis. 2012;54(8):e72-112.

Indian Council of Medical Research. Guidelines. New Delhi: Indian Council of Medical Research. Available at: https://www.icmr.gov.in/guidelines. Accessed on 05 August 2026.

Shulman ST, Bisno AL, Clegg HW, Gerber MA, Kaplan EL, Lee G, et al. Clinical practice guideline for the diagnosis and management of group A streptococcal pharyngitis: 2012 update by the IDSA. Clin Infect Dis. 2012;55(10):e86-e102.

Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, et al. Real-world evidence: what is it and what can it tell us? N Engl J Med. 2016;375(23):2293-7.

Blonde L, Khunti K, Harris SB, Meizinger C, Skolnik NS. Interpretation and impact of real-world clinical data for the practicing clinician. Adv Ther. 2018;35(11):1763-74.

Wald ER, Chiponis D, Ledesma-Medina J. Comparative effectiveness of amoxicillin and amoxicillin-clavulanate potassium in acute paranasal sinus infections in children: a double-blind, placebo-controlled trial. Pediatrics. 1986;77(6):795-800.

Garbutt JM, Goldstein M, Gellman E, Shannon W, Littenberg B. A randomized, placebo-controlled trial of antimicrobial treatment for children with clinically diagnosed acute sinusitis. Pediatrics. 2001;107(4):619-25.

Shaikh N, Hoberman A, Shope TR, Jeong JH, Kurs-Lasky M, Martin JM, et al. Identifying children likely to benefit from antibiotics for acute sinusitis: a randomized clinical trial. JAMA. 2023;330(4):349-58.

Bucher HC, Tschudi P, Young J, Périat P, Züst H, et al. Effect of amoxicillin-clavulanate in clinically diagnosed acute rhinosinusitis: a placebo-controlled, double-blind, randomized trial in general practice. Arch Intern Med. 2003;163(15):1793-8.

Ray R, Manavadaria AD, Mitra M, Gandhi S, Yadav N, Wari P, et al. Clinical outcomes with high-dose amoxycillin-clavulanate suspension in children with respiratory tract infections: a prospective, multicentre, phase IV study in India. Adv Ther. 2026;NA.

Llor C, Bayona C, Hernández S, Moragas A, Miravitlles M. Comparison of adherence between twice- and thrice-daily regimens of oral amoxicillin/clavulanic acid. Respirology. 2012;17(4):687-92.

Falagas ME, Karageorgopoulos DE, Moraitis LI, Vouloumanou EK, Roussos N, Peppas G, et al. Compliance with once-daily versus twice or thrice-daily administration of antibiotic regimens: a meta-analysis of randomized controlled trials. PLoS One. 2015;10(1):e0116207.

Lamdhade V, Warhade K, Gondane A, Pal A, Marda U, Pawar D, Sharma A. Multicenter, retrospective, real-world evidence study to evaluate the effectiveness of cefpodoxime in the management of patients with respiratory tract infections. Int J Med Pharm Res. 2026;7(2):3664-70.