Safety evaluation of piperacillin/tazobactam in very low birth weight infants.
An open, non-comparative study was designed to evaluate the safety and tolerance 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, particularly those involving the gastrointestinal tract. Comparative clinical trials are warranted to further clarify the microbiological efficacy of piperacillin/tazobactam in this particular patient population.
Berger
A
A
Department of Neonatology, University Hospital, Vienna, Austria. angelika.berger@akh-wien.ac.at
Kretzer
V
V
Apfalter
P
P
Rohrmeister
K
K
Zaknun
D
D
Pollak
A
A
D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016470:Bacteremia / Q000188:drug therapy / Q000473:pathology; D003428:Cross Infection / Q000188:drug therapy* / Q000473:pathology; D004359:Drug Therapy, Combination; D020345:Enterocolitis, Necrotizing / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D016905:Gram-Negative Bacterial Infections / Q000188:drug therapy / Q000473:pathology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D019102:Infant, Very Low Birth Weight; D008297:Male; D010397:Penicillanic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D010878:Piperacillin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D000078142:Tazobactam; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D010397:Penicillanic Acid; D000078142:Tazobactam; D010878:Piperacillin