Real-World Evidence on the Clinical Effectiveness and Safety of Faropenem in the Management of Paediatric Upper Respiratory Tract Infections: A Multicentre Retrospective Study

Objectives: To evaluate real-world evidence on the clinical effectiveness and safety of faropenem in the management of upper respiratory tract infections (URTIs) in Indian paediatric patients. Methods: This multicentre, retrospective study analyzed medical records of paediatric patients (≤12 years) treated with faropenem oral suspension for URTIs. Records with complete and evaluable clinical data were included. Data collected comprised type of URTI, prescribed and actual duration of therapy, dosage and dosing frequency, laboratory parameters such as white blood cell (WBC) count and C-reactive protein (CRP) levels (where available), clinical outcomes, and adverse events. Assessments were conducted at baseline and follow-up, and results were analyzed using descriptive statistics. Results: A total of 965 records (673 males; 292 females) were evaluated, with a mean age of 7.65 ± 2.87 years. Diagnoses included undifferentiated URTI (n=648), acute otitis media (n=142), tonsillitis (n=81), pharyngitis (n=79), and acute sinusitis (n=15). The mean prescribed and actual treatment durations were 5.96 ± 1.83 and 5.87 ± 1.81 days, respectively. Faropenem was administered twice daily in 309 patients and thrice daily in 656 patients. Clinical cure was achieved in 505 patients (52.33%), while 460 (47.67%) showed improvement. Among patients with available laboratory data, elevated baseline CRP and WBC values normalized in the majority at follow-up (CRP: 88%; WBC: 84%). No major adverse events were reported. Conclusion: Faropenem demonstrated excellent real-world effectiveness and safety in paediatric URTIs. Consistent clinical improvement and normalization of inflammatory markers support its role as a well-tolerated therapeutic option in this population. Key words: Oral carbapenem, Real-world data, Clinical outcomes, Inflammatory biomarkers