Efficacy and renal toxicity of one daily dose of amikacin versus conventional dosage regime.

Author(s): Guadalupe Vasquez-Mendoza M, Vargas-Origel A, Del Carmen Ramos-Jimenez A, Aguilar-Orozco G, Romero-Gutierrez G

Affiliation(s): Department of Neonatology, Hospital de GinecoPediatria 48, Mexican Institute of Social Security, Leon, Guanajuato, Mexico.

Publication date & source: 2007-02, Am J Perinatol., 24(2):141-6. Epub 2007 Feb 15.

Publication type: Randomized Controlled Trial

This study assessed the efficacy and renal toxicity of one daily dose of amikacin versus several doses in infected full-term newborns. A clinical trial was conducted with 120 patients who were divided into two groups: group A (n = 60), infants who received amikacin 20 mg/kg/d in one dose; and group B (n = 60), infants who received amikacin 10 mg/kg/d every 12 hours. Both groups also received ampicillin 100 mg/kg/day. Blood levels of amikacin, urinary beta(2)-microglobulin (beta(2)-m), serum creatinine (SCr), and glomerular filtration rate (GFR) were measured in each patient. No significant difference was found in demographic characteristics as well as in their beta(2)-m, SCr, and GFR levels. Infection was resolved in 96% for infants of group A and 91% for group B ( P = 0.254). Renal toxicity was present in 20 versus 31.6%, respectively ( P = 0.211). In both groups no significant difference was found in peak amikacin levels, whereas trough levels were higher for group B ( P = 0.004). No significant difference was found in efficacy or renal toxicity in either group. We recommend using amikacin in one daily dose. It could diminish the manipulation of intravenous access, reducing the risk of nosocomial infections.