Safety evaluation of piperacillin/tazobactam in very low birth weight infants.

AbstractAn open, non-comparative study was designed to evaluate the safety and toler-ance of parenteral piperacillin/tazobactam in very low birth weight infants. Twenty-seven patients were included for nosocomial sepsis with Gram-negative bacteria (n = 4), nosocomial sepsis not responding to the empirical antibiotic regimen (n = 3), suspected necrotizing enterocolitis (n = 17), and infection after abdominal surgery for reasons other than necrotizing enterocolitis (n = 3). No clinical adverse events considered related to the study drug were noted, in particular, no cases of phlebitis, rash or stool changes. Several possibly related, mild and transitory abnormalities of laboratory parameters were observed. No long-lasting effect on the intestinal flora was detected. Seventeen patients (63%) were considered to have a favorable clinical response. This study demonstrates that piperacillin/tazobactam is a safe and well tolerated drug for preterm infants with bacterial infections, particu-larly those involving t...