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Efficacy and safety of roxithromycin in treating paediatric patients. A European multicentre study
1University of Athens, Second Department of Paediatrics A. Kyriakou Children's Hospital, Greece.
Insights
Roxithromycin sachets effectively treated common respiratory and skin infections in 304 children. This safe oral antibiotic showed high cure rates with minimal adverse effects, primarily vomiting.
Area of Science:
- Pediatric Infectious Diseases
- Clinical Pharmacology
- Microbiology
Background:
- Respiratory and skin infections are common in pediatric populations.
- Oral antibiotics are crucial for treating these infections in children.
- Evaluating the efficacy and safety of new antibiotic formulations is essential.
Purpose of the Study:
- To assess the clinical and bacteriological efficacy of roxithromycin sachets in pediatric patients.
- To determine the safety and tolerability profile of roxithromycin in infants and children.
- To evaluate roxithromycin as a treatment option for common pediatric infections.
Main Methods:
- A clinical trial involving 304 infants and children (2 months to 14 years) with respiratory or skin infections.
- Administration of roxithromycin sachets at dosages of 2.5 to 5.0 mg/kg every 12 hours for a mean of 8.9 days.
- Evaluation of clinical cure rates, bacteriological eradication, and adverse events.
Main Results:
- A clinical cure rate of 89% was observed in 266 evaluable children.
- Bacteriological efficacy reached 82% in identified cases, with a 90.3% cure rate in bacteriologically confirmed infections.
- Roxithromycin was well-accepted by 90% of patients; adverse effects (mainly vomiting) occurred in 6.9% with no toxic effects.
Conclusions:
- Roxithromycin sachets demonstrate significant clinical and bacteriological efficacy in treating pediatric respiratory and skin infections.
- The antibiotic is safe and well-tolerated in the pediatric population, with a low incidence of mild adverse effects.
- Roxithromycin is a viable and effective oral treatment option for common infections in children.
Abstract:
Roxithromycin sachets of 50 mg were given to 304 infants and children, aged 2 months to 14 years, suffering from respiratory and skin infections treated in 25 hospitals in France and one in Greece. The dosage range was from 2.5 to 5.0 mg/kg/12 h and the mean duration of therapy was 8.9 days. The cure rate was 89% of the 266 children evaluable for clinical efficacy and 90.3% of the 50 bacteriologically identified cases. The overall bacteriological efficacy was 82%. The antibiotic was well accepted by the 90% of the 304 children, while in 6.9% an adverse effect was reported, mainly vomiting. There were no toxic effects. Roxithromycin should be considered as an effective and safe oral antibiotic to treat children with upper and lower respiratory tract and skin infections due to common pathogens.