Tolerability and Outcomes of Kinetically Guided Therapy With Gentamicin in Critically Ill Neonates During the First Week of Life: An Open-Label, Prospective Study

Clinical Therapeutics

Volumn 32, Issue 14, 2010, Pages 2400-2414

  Martínková, Jirina ^a   Pokorná, Pavla ^b   Záhora, Jiri ^a   Chládek, Jaroslav ^a   Vobruba, Václav ^b   Selke Krulichová, Iva ^a   Chládková, Jirina ^a  

^a CHARLES UNIVERSITY   (Czech Republic)

^b CHARLES UNIVERSITY   (Czech Republic)

Author keywords

Aminoglycosides; Gentamicin; Neonates; Sepsis; Tolerability

Indexed keywords

AMIKACIN; AMPICILLIN; BIOLOGICAL MARKER; C REACTIVE PROTEIN; GENTAMICIN; SULTAMICILLIN; VANCOMYCIN;

ANTIBIOTIC THERAPY; ARTICLE; BIRTH WEIGHT; BLOOD CULTURE; BODY WEIGHT; CAUSE OF DEATH; CLINICAL TRIAL; COMORBIDITY; CORRELATION ANALYSIS; CRITICALLY ILL PATIENT; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; ECHOGRAPHY; ESCHERICHIA COLI; EVOKED OTOACOUSTIC EMISSION; FATALITY; FEMALE; FLUID INTAKE; FLUID RETENTION; GESTATIONAL AGE; HUMAN; KIDNEY CALCIFICATION; KIDNEY DYSFUNCTION; KLEBSIELLA OXYTOCA; LISTERIA MONOCYTOGENES; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MINIMUM INHIBITORY CONCENTRATION; NEPHROTOXICITY; NEWBORN; NEWBORN INFECTION; NEWBORN INTENSIVE CARE; OPEN STUDY; OPTIMAL DRUG DOSE; OTOTOXICITY; OUTCOME ASSESSMENT; PNEUMONIA; PROSPECTIVE STUDY; PSEUDOMONAS AERUGINOSA; SEPSIS; STAPHYLOCOCCUS AUREUS; STAPHYLOCOCCUS EPIDERMIDIS; STAPHYLOCOCCUS SAPROPHYTICUS; TREATMENT DURATION; TREATMENT RESPONSE; UNILATERAL HEARING LOSS; URINE VOLUME;

ANTI-BACTERIAL AGENTS; BIRTH WEIGHT; CRITICAL ILLNESS; DRUG ADMINISTRATION SCHEDULE; GENTAMICINS; GESTATIONAL AGE; HUMANS; INFANT, NEWBORN; INTENSIVE CARE UNITS, NEONATAL; INTENSIVE CARE, NEONATAL; MALE; PROSPECTIVE STUDIES; SEPSIS; TIME FACTORS; TREATMENT OUTCOME;

EID: 79951841262     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2011.01.013     Document Type: Article

References (58)

1. Barriere S.L. Bacterial resistance to beta-lactams, and its prevention with combination antimicrobial therapy. Pharmacotherapy 1992, 12:397-402.
2. García B., Barcia E., Pérez F., Molina I.T. Population pharmacokinetics of gentamicin in premature newborns. J Antimicrob Chemother 2006, 58:372-379.
3. Moore R.D., Smith C.R., Lietman P.S. The association of aminoglycoside plasma levels with mortality in patients with gram-negative bacteremia. J Infect Dis 1984, 149:443-448.
4. Moore R.D., Smith C.R., Lipsky J.J., et al. Risk factors for nephrotoxicity in patients treated with aminoglycosides. Ann Intern Med 1984, 100:352-357.
5. McCormack J.P., Jewesson P.J. A critical reevaluation of the "therapeutic range" of aminoglycosides. Clin Infect Dis 1992, 14:320-339.
6. Hansen M., Christrup L.L., Jarløv J.O., et al. Gentamicin dosing in critically ill patients. Acta Anaesthesiol Scand 2001, 45:734-740.
7. Nicolau D.P., Freeman C.D., Belliveau P.P., et al. Experience with a once-daily aminoglycoside program administered to 2,184 adult patients. Antimicrob Agents Chemother 1995, 39:650-655.
8. Avent M.L., Kinney J.S., Istre G.R., Whitfield J.M. Gentamicin and tobramycin in neonates: Comparison of a new extended dosing interval regimen with a traditional multiple daily dosing regimen. Am J Perinatol 2002, 19:413-420.
9. De Paepe P., Belpaire F.M., Buylaert W.A. Pharmacokinetic and pharmacodynamic considerations when treating patients with sepsis and septic shock. Clin Pharmacokinet 2002, 41:1135-1151.
10. Marik P.E. Aminoglycoside volume of distribution and illness severity in critically ill septic patients. Anaesth Intensive Care 1993, 21:172-173.
11. Buijk S.E., Mouton J.W., Gyssens I.C., et al. Experience with a once-daily dosing program of aminoglycosides in critically ill patients. Intensive Care Med 2002, 28:936-942.
12. Power B.M., Forbes A.M., van Heerden P.V., Ilett K.F. Pharmacokinetics of drugs used in critically ill adults. Clin Pharmacokinet 1998, 34:25-56.
13. van Dalen R., Vree T.B. Pharmacokinetics of antibiotics in critically ill patients. Intensive Care Med 1990, 16(Suppl 3):S235-S238.
14. Triginer C., Izquierdo I., Fernández R., et al. Gentamicin volume of distribution in critically ill septic patients. Intensive Care Med 1990, 16:303-306.
15. Reimann I.R., Meier-Hellmann A., Reinhart K., Hoffmann A. Comments to consensus document. Once-daily dosing of aminoglycosides from N. Anaizi. A supplement to dosage and monitoring in critically ill patients. Int J Clin Pharmacol Ther 1997, 35:397.
16. Niemiec P.W., Allo M.D., Miller C.F. Effect of altered volume of distribution on aminoglycoside levels in patients in surgical intensive care. Arch Surg 1987, 122:207-212.
17. Agras P.I., Tarcan A., Baskin E., et al. Acute renal failure in the neonatal period. Ren Fail 2004, 26:305-309.
18. Mathur N.B., Agarwal H.S., Maria A. Acute renal failure in neonatal sepsis. Indian J Pediatr 2006, 73:499-502.
19. Craig W.A. Once-daily versus multiple-daily dosing of aminoglycosides. J Chemother 1995, 7(Suppl 2):47-52.
20. Stoll B.J., Hansen N.I., Adams-Chapman I., et al. Neurodevelopmental and growth impairment among extremely low-birth-weight infants with neonatal infection. JAMA 2004, 292:2357-2365. National Institute of Child Health and Human Development Neonatal Research Network.
21. Gross I., Vallard P.L. Hormonal therapy for prevention of respiratory distress syndrome. Fetal and Neonatal Physiology 2004, 1069-1073. Saunders, Philadelphia, Pa. 3rd ed. R.A. Polin, W.W. Fox, S.H. Abman (Eds.).
22. Xanthou M., Fotopoulos S., Mouchtouri A., et al. Inflammatory mediators in perinatal asphyxia and infection. Acta Paediatr Suppl 2002, 91:92-97.
23. Isemann B.T., Kotagal U.R., Mashni S.M., et al. Optimal gentamicin therapy in preterm neonates includes loading doses and early monitoring. Ther Drug Monit 1996, 18:549-555.
24. Young T.E., Mangum O.B. Neofax: A Manual of Drugs Used in Neonatal Care 2002, 1-65. Acorn Publishing, Raleigh, NC. 15th ed.
25. Wagner J.G. Pharmacokinetics for the Pharmaceutical Scientist 1993, Technomic Publishing, Lancaster, Pa.
26. Sheiner L.B., Beal S.L. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm 1981, 9:503-512.
27. Ganong W.F. Dynamics of blood and lymph flow. Review of Medical Physiology 1993, 579-598. McGraw-Hill Professional, Lange Medical Books, New York, NY. 21st ed.
28. Goldstein B., Giroir B., Randolph A. International pediatric sepsis consensus conference: Definitions for sepsis and organ dysfunction in pediatrics. Pediatr Crit Care Med 2005, 6:2-8. International Consensus Conference on Pediatric Sepsis.
29. Narendra A., White M.P., Rolton H.A., et al. Nephrocalcinosis in preterm babies. Arch Dis Child Fetal Neonatal Ed 2001, 85:F207-F213.
30. Sweileh W.M. A prospective comparative study of gentamicin- and amikacin-induced nephrotoxicity in patients with normal baseline renal function. Fundam Clin Pharmacol 2009, 23:515-520.
31. Modi N., Doré C.J., Saraswatula A., et al. A case definition for national and international neonatal bloodstream infection surveillance. Arch Dis Child Fetal Neonatal Ed 2009, 94:F8-F12.
32. Sarnat H.B., Sarnat M.S. Neonatal encephalopathy following fetal distress. A clinical and electroencephalographic study. Arch Neurol 1976, 33:696-705.
33. Yaffe S.J. Antimicrobial therapy and the neonate. Obstet Gynecol 1981, 58(Suppl 5):85S-94S.
34. Koren G., James A., Perlman M. A simple method for the estimation of glomerular filtration rate by gentamicin pharmacokinetics during routine drug monitoring in the newborn. Clin Pharmacol Ther 1985, 38:680-685.
35. Alcorn J., McNamara P.J. Ontogeny of hepatic and renal systemic clearance pathways in infants: Part I. Clin Pharmacokinet 2002, 41:959-998.
36. Semchuk W., Borgmann J., Bowman L. Determination of a gentamicin loading dose in neonates and infants. Ther Drug Monit 1993, 15:47-51.
37. Brace R.A. Fluid distribution in the fetus and neonate. Fetal and Neonatal Physiology 2004, 1341-1350. Saunders, Philadelphia, Pa. 3rd ed. R.A. Polin, W.W. Fox, S.H. Abman (Eds.).
38. Matsuda N., Hattori Y. Vascular biology in sepsis: Pathophysiological and therapeutic significance of vascular dysfunction. J Smooth Muscle Res 2007, 43:117-137.
39. Hotz H.G., Foitzik T., Rohweder J., et al. Intestinal microcirculation and gut permeability in acute pancreatitis: Early changes and therapeutic implications. J Gastrointest Surg 1998, 2:518-525.
40. Serour F., Dan M., Gorea A., et al. Penetration of aminoglycosides into human peritoneal tissue. Chemotherapy 1990, 36:251-253.
41. Stonestreet B.S., Bell E.F., Oh W. Validity of endogenous creatinine clearance in low birthweight infants. Pediatr Res 1979, 13:1012-1014.
42. Saarela T., Lanning P., Koivisto M. Prematurity-associated nephrocalcinosis and kidney function in early childhood. Pediatr Nephrol 1999, 13:886-890.
43. Gordjani N., Burghard R., Leititis J.U., Brandis M. Serum creatinine and creatinine clearance in healthy neonates and prematures during the first 10 days of life. Eur J Pediatr 1988, 148:143-145.
44. Nielsen E.I., Sandström M., Honoré P.H., et al. Developmental pharmacokinetics of gentamicin in preterm and term neonates: Population modelling of a prospective study. Clin Pharmacokinet 2009, 48:253-263.
45. Holford N.H. Pharmacokinetics and pharmacodynamics: Rational dosing and the time course of drug action. Basic and Clinical Pharmacology 2009, 37. McGraw-Hill Medical, New York, NY. 11th ed. B.G. Katzung, S.B. Masters, A.J. Trevor (Eds.).
46. Spitzer A.R., Kirkby S., Kornhauser M. Practice variation in suspected neonatal sepsis: A costly problem in neonatal intensive care. J Perinatol 2005, 25:265-269.
47. Kumar Y., Qunibi M., Neal T.J., Yoxall C.W. Time to positivity of neonatal blood cultures. Arch Dis Child Fetal Neonatal Ed 2001, 85:F182-F186.
48. Dillon J.J. Nephrotoxicity from antibacterial, antifungal and antiviral drugs. Acute Renal Failure: A Companion to Brenner and Rector's the Kidney 2001, 349-364. Saunders, Philadelpia, Pa. 6th Edition. B.A. Molitoris, W.F. Finn (Eds.).
49. Martínez-Salgado C., López-Hernández F.J., López-Novoa J.M. Glomerular nephrotoxicity of aminoglycosides. Toxicol Appl Pharmacol 2007, 223:86-98.
50. Patzer L. Nephrotoxicity as a cause of acute kidney injury in children. Pediatr Nephrol 2008, 23:2159-2173.
51. Chesney R.W., Jones D.P. Nephrotoxins. Pediatric Nephrology 2004, 987-1004. Lippincott Williams & Wilkins, Philadelphia, Pa. 5th ed. E.D. Avner, W.E. Harmon, P. Niaudet (Eds.).
52. Pokorná P, Martinková J, Záhora J, et al. Therapeutic drug monitoring of gentamicin in neonates critically ill at the 1st week of life. Presented at the IXth World Conference on Clinical Pharmacology and Therapeutics, July 27-August 1, 2008. Quebec, Ontario, Canada. Poster T4W167.
53. Allegaert K., Anderson B.J., van den Anker J.N., et al. Renal drug clearance in preterm neonates: Relation to prenatal growth. Ther Drug Monit 2007, 29:284-291.
54. Bareggi R., Narducci P., Grill V., et al. Localization of an aminoglycoside (streptomycin) in the inner ear after its systemic administration. A histochemical study using fluorescence microscopy. Histochemistry 1986, 84:237-240.
55. Lii M., Ding D., Zheng X.Y., Salvi R. Vestibular destruction by slow infusion of gentamicin into semicircular canals. Acta Otolaryngol Suppl 2004, 552:35-41.
56. Forge A., Li L. Apoptotic death of hair cells in mammalian vestibular sensory epithelia. Hear Res 2000, 139:97-115.
57. Hille E.T., van Straaten H.I., Verkerk P.H. Prevalence and independent risk factors for hearing loss in NICU infants. Acta Paediatr 2007, 96:1155-1158. Dutch NICU National Hearing Screening Working Group.
58. Bates D.E. Aminoglycoside ototoxicity. Drugs Today (Barc) 2003, 39:277-285.