A controlled study of the nephrotoxicity of mezlocillin and gentamicin plus ampicillin in the neonate.

The nephrotoxicity of the aminoglycoside gentamicin was evaluated in an open, controlled study of newborn infants randomly allocated to receive either combination drug therapy with gentamicin and ampicillin or single drug therapy with mezlocillin for treatment of presumed neonatal sepsis. There were no significant differences in initial clinical characteristics between the groups. Neonates receiving gentamicin, in contrast to those receiving mezlocillin, had significant nephrotoxicity manifested by a smaller postnatal fall in mean serum creatinine concentration (-9%, P NS vs -21%, P less than 0.005, respectively) and a diminished postnatal rise in mean creatinine clearance (+ 21%, P NS vs + 51%, P less than 0.01, respectively). In neonates with a fall in creatinine clearance, the mean decline was significantly greater in those receiving gentamicin (44% vs 20%, P less than 0.01). There was no relationship between the incidence of gentamicin nephrotoxicity and either peak or trough gentamicin levels. For treatment of presumed neonatal sepsis, gentamicin proved more nephrotoxic than mezlocillin.

RCT Entities:   Population Interventions Outcomes