Efficacy and Safety of Sarclav in the Treatment of Acute Otitis Media in Children

Abstract

Background

Acute otitis media (AOM) is a community-acquired respiratory tract infection in childhood frequently encountered by primary-care physicians and can cause a significant morbidity. Increasing bacterial resistance has led to concern about the current options for empirical antibiotic treatment and has prompted a search for effective treatments.

Objectives

To evaluate the clinical efficacy and safety of Sarclav (cefpodoxime proxetil) in the treatment of children with acute otitis media.

Patients and Method

A prospective, multicenter study was conducted on 1380 children aged from 1 to 13 years with AOM who were prescribed a 5–10 day course of Sarclav (cefpodoxime proxetil) (8 mg/kg/day). Patients were followed-up after 7–14 days from baseline visit. Efficacy was assessed by the percentage of patients with clinical cure, improvement or failure at the follow-up visit. Safety was evaluated by recording the occurrence and severity of any adverse events and by the physicians’ and patients’ assessment of overall tolerability.

Results

Clinically, 82.5% of patients were cured, 16.4% were improved and there was failure of therapy in 1.1% of the patients. The overall combined cure and improvement rate of all related signs and symptoms was 98.9%. Adverse events, diarrhea and skin rash, were reported by only 16 patients (1.2%). The overall tolerability according to the physicians’ and patients’ assessment was excellent in 93.9% and 88.9%, respectively. Compliance was attained in 99.5% of patients.

Conclusion

Sarclav (cefpodoxime proxetil) is an effective, safe, well-tolerated antimicrobial agent for treatment of acute otitis media in children. It can be considered as an excellent choice for the empirical treatment of bacterial AOM.