Safety and efficacy of meropenem in hospitalised children: randomised comparison with cefotaxime, alone and combined with metronidazole or amikacin. Meropenem Paediatric Study Group.

In this multicentre, randomised study of 170 children hospitalised with bacterial infections, meropenem (10 to 20 mg/kg every 8 h) was found to be as effective and as well tolerated as cefotaxime (100 to 150 mg/kg/day), with or without amikacin or metronidazole. Most drug-related adverse events were mild and self-limiting. Neither regimen was associated with seizures. The overall incidence of clinically significant laboratory changes was similar in the two treatment groups. Satisfactory clinical responses were obtained in 94/96 (98%) patients treated with meropenem monotherapy and 43/46 (93%) children treated with cefotaxime regimens, while satisfactory bacteriological responses were obtained in 25/28 (89%) and 9/10 (90%) patients, respectively. Meropenem monotherapy appears to be a well-tolerated and effective drug for paediatric infections.