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The overall safety of oral roxithromycin in paediatric clinical studies
Insights
Roxithromycin sachets effectively treated infections in children. Most adverse events were mild digestive issues, with few discontinuations, indicating good overall safety for pediatric use in respiratory and skin infections.
Area of Science:
- Pediatric Infectious Diseases
- Clinical Pharmacology
Background:
- Respiratory tract infections and skin/soft tissue infections are common in children.
- Macrolide antibiotics like roxithromycin are frequently used for bacterial infections.
Purpose of the Study:
- To evaluate the safety and efficacy of roxithromycin in pediatric patients with common infections.
- To assess the incidence and nature of adverse events associated with roxithromycin treatment in children.
Main Methods:
- Two multicenter, non-comparative studies included 477 children aged 2 months to 15 years.
- Roxithromycin (50 mg sachets) was administered at a mean daily dose of 6 mg/kg/day, divided twice daily, for a mean of 9 days.
- Safety assessment involved monitoring adverse events, treatment discontinuations due to adverse events, and laboratory data.
Main Results:
- Adverse events possibly related to roxithromycin were reported in 4% of children, primarily mild to moderate gastrointestinal issues.
- Treatment discontinuation due to adverse events occurred in only 1% of participants.
- Laboratory data showed minor variations without clinical significance.
Conclusions:
- Roxithromycin demonstrated a favorable safety profile in children treated for respiratory tract and skin/soft tissue infections.
- The low incidence of significant adverse events suggests roxithromycin is a well-tolerated option for pediatric infectious diseases.
Abstract:
In two multicentre, non-comparative studies, a total of 477 children, aged 2 months to 15 years, suffering from respiratory tract infections or skin and soft tissue infections were treated with roxithromycin (50 mg sachets). The mean duration of treatment was 9 days and the mean daily dose was 6 mg/kg/day administered b.i.d. The overall safety of roxithromycin was assessed by analysing the adverse events reported by the patients or investigators, the discontinuation of treatment because of adverse events, and the laboratory data. Adverse events reported by 20 (4%) children were considered to be possibly drug related. These adverse events were mainly digestive in nature and mild or moderate in severity. Treatment was discontinued because of adverse events in six (1%) children. Analysis of laboratory data revealed a few variations without any clinical significance.