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[Bacteriological and clinical studies of SY5555 in pediatric field]
T Nishimura1, K Sugita, S Aoki
1Department of Pediatrics, Osaka Medical College.
Insights
SY5555, a novel oral penem antibiotic, demonstrated high clinical efficacy (96.8%) in pediatric patients across various infections. Bacteriological eradication rates were also promising, with a low incidence of side effects observed.
Area of Science:
- Pediatric infectious diseases
- Pharmacology
- Clinical microbiology
Background:
- Emerging antibiotic resistance necessitates novel therapeutic options.
- Penem antibiotics offer broad-spectrum activity against various bacterial pathogens.
Purpose of the Study:
- To evaluate the clinical efficacy and safety of SY5555, a new oral penem, in pediatric patients.
- To assess the bacteriological eradication rates of SY5555 against common pediatric pathogens.
Main Methods:
- Open-label clinical studies were conducted.
- Patients diagnosed with pharyngitis, tonsillitis, scarlet fever, impetigo, balanitis, cellulitis, and urinary tract infections (UTI) were enrolled.
- Bacteriological efficacy was assessed against identified pathogens like Staphylococcus aureus and Streptococcus pyogenes.
Main Results:
- SY5555 achieved a high clinical efficacy rate of 96.8% (30/31 patients).
- Bacteriological eradication rate was 81.0% against tested pathogens.
- The most common side effect was loose stool; laboratory abnormalities included eosinophilia and thrombocytosis in a few patients.
Conclusions:
- SY5555 shows significant clinical and bacteriological efficacy in treating pediatric infections.
- The safety profile of SY5555 appears favorable, with mild and infrequent side effects.
- SY5555 represents a potential new therapeutic option for pediatric infectious diseases.
Abstract:
Clinical studies were carried out on SY5555, a new oral penem, in the field of pediatrics. The results obtained are summarized below. The clinical efficacies were examined in a total 31 patients consisting of 4 patients with pharyngitis, 10 with purulent tonsillitis, 4 with scarlet fever, 7 with impetigo, one with balanitis, one with cellulitis and 4 with UTI. The clinical efficacy rate was 96.8% (30/31). Bacteriological efficacies of SY5555 were examined on identified pathogens including 7 strains of Staphylococcus aureus, 6 of Streptococcus pyogenes, 3 of Enterococcus faecalis, 3 of Haemophilus influenzae, one of Escherichia coli and one of Citrobacter freundii. The bacteriological eradication rate was 81.0%. As for side effects, loose stool in one patient was noted. Abnormal laboratory findings test results included eosinophilia in 2 patients, eosinophilia and elevation of serum transaminase in one patient, and thrombocytosis in another.