Safety and Efficacy of Faropenem in Respiratory-and Urinary Tract Infections: A Prospective Observational Study in Pediatric Patients

Introduction: Faropenem, the only penem antibiotic for oral administration, is crucial for treating pediatric infections with limited supporting evidence. Objectives: To assess the safety and efficacy of faropenem in pediatric infections, RTIs, and UTIs. Methods: This prospective, multicentric, observational study (CTRI/2024/01/061255; 09/01/2024) enrolled male and female patients, aged ≥6 months to <18 years, diagnosed with RTIs or UTIs, treated with faropenem sodium dry syrup (100mg/5ml) at investigator's discretion. Follow-up assessments occurred on Days 7±2 and 14±2. Primary outcome was the incidence of TEAEs and SAEs. Secondary outcomes included proportions of patients with clinical improvement (≥50% symptom resolution without antibiotic change), clinical cure (complete symptom resolution), treatment failure (symptom worsening or therapy modification), and bacteriological cure (<1000 CFU/ml for UTI). Results: Of 200 patients [54.50% females; mean age of 6.37±3.83 years], 197 completed the study without any reported TEAE/SAE. Clinical improvement at Day 7±2 was evident in all patients with pharyngitis, tonsillitis, and acute bronchitis; 98.57% with CABP, 89.47% with UTI, and 83.33% with ABRS. Early clinical cure rate at Day 7±2 was: pharyngitis and tonsillitis, 91.84%; CABP, 75.71%; UTI, 75.44%; acute bronchitis, 66.67%; ABRS, 33.37%. Clinical cure rate at Day 14±2 was: acute bronchitis and ABRS, 100.00%; UTI, 98.25%; pharyngitis and tonsillitis, 97.66%; CABP, 97.14%. Therapy modification was not required in any patient. Symptoms deteriorated in one patient with pharyngitis and tonsillitis. Bacteriological cure was observed in all evaluated patients with UTI. Conclusions: Faropenem was found to be safe and effective for the treatment of RTIs and UTIs in children.