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To compare the efficacy and safety of meropenem with cefotaxime for the treatment of infants and children with bacterial meningitis.Infants and children with strongly suspected or documented bacterial meningitis were randomly assigned in a prospective multicenter study to receive either meropenem or cefotaxime. Patients were assessed at the end of therapy and at 5 to 7 weeks and 5 to 7 months after the end of treatment for the presence of neurologic and sensory neural sequelae.A total of 258 children were randomized to either treatment group. A further 8 patients with suspected pneumococcal meningitis were treated with meropenem without randomization. Of the randomized patients 154 were fully evaluable, 79 in the meropenem group and 75 in the cefotaxime group. At the end of treatment there were no significant differences in clinical outcome between the two treatment groups. Clinical cure with or without sequelae was achieved in 97 and 96% of the meropenem- and cefotaxime-treated patients, respectively. At the end of treatment and at 5 to 7 weeks, 46 and 54% of meropenem patients were cured with no sequelae, respectively. Corresponding results for cefotaxime patients were 56 and 58%. All pathogens were eradicated. In total 37 patients had seizures during treatment, 15 (12%) in the meropenem and 22 (17%) in the cefotaxime group. None of the seizures was considered to be drug-related.This trial shows that meropenem is suitable therapy for bacterial meningitis in infants and children and that it offers an efficacy and safety profile similar to that of cefotaxime.

Between August 1977 and January 1979, 16 children (7 males and 9 females) ranging in age from 5 to 38 months (mean age 18 months) were treated with trimethoprim-sulfamethoxazole (TMP-SMX) (40 mg/kg SMX per 24 hours) for otitis media caused by beta-lactamase strains of ampicillin-resistant Haemophilus influenzae. Fourteen patients had failed after antecedent ten-day courses of ampicillin (9 patients) or amoxicillin (5 patients) therapy. The remaining two patients received only five days of ampicillin before changing to TMP-SMX. Six of the isolates were nontypable, 3 were type B, 5 isolates were Haemophilus parainfluenzae, and 2 strains were unavailable for typing. Of 13 strains tested, 10 had a minimal inhibitory concentration (MIC) in excess of 3.12 microgram/ml of ampicillin; the remaining 3 had an MIC of3.12 microgram/ml. All 13 isolates were susceptible to 0.19 microgram/ml TMP-SMX. Five of 16 children were symptomatic (irritable; fever of38.2 C); within three days of starting TMP-SMX treatment, they became asymptomatic. Fifteen of 16 patients (93%) responded favorably after ten days of TMP-SMX. Only one patient had H influenzae resistant to ampicillin (12.5 microgram/ml) and sensitive to TMP-SMX (0.19 microgram/ml) isolated from the middle ear at the end of ten days of TMP-SMX. At the end of TMP-SMX therapy, middle ear effusions were noted in ten patients; the fluid was sterile in the four patients who had a second tympanocentesis. There were two recurrences within one month of TMP-SMX therapy. No adverse clinical reactions were noted.

Infusions of 50 mg of sulbactam per kg per day and 400 mg of ampicillin per kg per day in divided doses to infants and children with bacterial meningitis produced levels in cerebrospinal fluid approximately one-third those in serum. Concentrations in cerebrospinal fluid of 5.5 micrograms of sulbactam per ml and 16.0 micrograms of ampicillin per ml declined within a few days of therapy to 1.9 microgram of sulbactam per ml and 5.2 micrograms of ampicillin per ml.