Clinical studies on SY5555 in pediatric infections

: Pharmacokinetic and clinical studies on SY5555, a new oral penem antibiotics, were performed in pediatric infections and the following results were obtained. 1. Pharmacokinetics studies Pharmacokinetics of SY5555 was studied in 5 children (5y1m-10y11m) using doses of 5 mg/kg (n = 3) and 10 mg/kg (n = 2). The average peak plasma levels were 0.65 microgram/ml at 1 or 2 hours after administration of 5 mg/kg and 2.12 micrograms/ml at 1 or 2 hours after administration of 10 mg/kg, and the plasma half-lives were 0.81 and 1.08 hours, respectively. Average cumulative urinary recovery rates at 0-6 hours were 2.97 and 3.96%, respectively. 2. Clinical studies SY5555 was administered to 45 patients with various infectious diseases (2 with acute pharyngitis, 8 with acute tonsillitis, 4 with lacunar tonsillitis, 3 each with acute bronchitis, pneumonia and pertussis, 7 with scarlet fever, 3 with impetigo contagiosa, 6 with acute urinary tract infections, 2 with balanoposthitis and 1 each with cervical lymphadenitis, S.S.S.S., vulvitis and acute colitis) at daily doses between 3.4-10 mg/kg, t.i.d., for 3-14 days. Clinical responses were excellent in 27 patients, good in 15 patients, fair in 1 patient, and poor in 2 patients, and the efficacy rate was 93.3%. Causative organisms were examined and 39 strains of 11 species were identified. The eradication rate was 78.9%. Side effects were observed in 1 patient with diarrhea. An abnormal laboratory test value was observed in 1 patient with elevation of eosinophils. The above results suggest that SY5555 may be a very useful and safe drug for the treatment of pediatric infection.