Clinical study of meropenem for infections in the pediatric field

The purpose of this study was to evaluate the efficacy, safety and PK profile of meropenem (MEPM) in the treatment of hospitalized infants and children with various infections. A total 52 patients, average 3.48 years old, were enrolled in the study. MEPM was administered intravenously every 8 hours at a daily dose of 10, 20 or 40 mg/kg. The overall favorable clinical response rate was 95.9% (47 out of 49 eligible patients). The breakdown of the clinical response rate was 96.2% (25/26) for RTI, 100% (6/6) for sepsis, 100% (5/5) for meningitis, 100% (3/3) for UTI and 88.9% (8/9) for the other infections. There were no sequelae or mortality in five cases of meningitis treated with 40 mg/kg MEPM. The microbiological response was satisfactory in 97.0% (30 cases of "Eradicated" plus 2 cases of "Presumed eradicated" out of 33 evaluable patients). The two most frequently isolated bacteria were Streptococcus pneumoniae (16 strains) and Haemophilus influenzae (21 strains). These strains were favorably susceptible to MEPM. Plasma MEPM concentrations at 20-30 min after infusion were 65.52-38.22 μg/mL on 40 mg/kg, 30.81-13.73 μg/mL on 20 mg/kg and 16.37-5.86 μg/mL on 10 mg/kg, respectively. Urinary recovery was 56.4-70.7% after administration up to 8 hours. Cerebrospinal fluid (CSF) MEPM level was sustained at 0.29-2.75 μg/mL up to 6 hours in the meningitis patients at a dose of 40 mg/kg. There were adverse drug reactions in 23 out of 52 patients, but no severe incidence was observed. In conclusion, MEPM appeared to be a useful agent for treatment of common infentions in infant and child patients at a dose of 10 or 20 mg/kg three times daily, and for severe infections such as meningitis at a dose of 40 mg/kg.