One dose per day compared to multiple doses per day of gentamicin for treatment of suspected or proven sepsis in neonates

Cochrane Database of Systematic Reviews

Volumn 2016, Issue 12, 2016, Pages

  Rao, Shripada C ^a   Srinivasjois, Ravisha ^b   Moon, Kwi ^c  

^a KING EDWARD MEMORIAL HOSPITAL   (Australia)

^b UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^c PRINCESS MARGARET HOSPITAL FOR CHILDREN   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

GENTAMICIN; ANTIINFECTIVE AGENT;

ANTIBIOTIC THERAPY; COMPARATIVE EFFECTIVENESS; DRUG DOSE COMPARISON; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; DRUG TREATMENT FAILURE; HUMAN; META ANALYSIS; MULTIPLE DRUG DOSE; NEPHROTOXICITY; NEWBORN; NEWBORN SEPSIS; OTOTOXICITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SYSTEMATIC REVIEW; DRUG ADMINISTRATION; DRUG EFFECTS; HEARING; KIDNEY; METABOLISM; SEPSIS;

ANTI-BACTERIAL AGENTS; DRUG ADMINISTRATION SCHEDULE; GENTAMICINS; HEARING; HUMANS; INFANT, NEWBORN; KIDNEY; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SEPSIS;

EID: 85002534722     PISSN: 14651858     EISSN: None     Source Type: Journal    
DOI: 10.1002/14651858.CD005091.pub4     Document Type: Review

References (96)

1. Agarwal G, Rastogi A, Pyati S, Wilks A, Pildes RS. Comparison of once-daily versus twice-daily gentamicin dosing regimens in infants > or = 2500 g. Journal of Perinatology 2002;22(4):268-74. [3386277]
2. Chotigeat U, Narongsanti A, Ayudhya DP. Gentamicin in neonatal infection: once versus twice daily dosage. Journal of Medical Association of Thailand 2001;84(8):1109-15. [3386279]
3. de Alba Romero C, Gomez Castillo E, Manzanares Secades C, Rodriguez Lopez J, Arreaza Lopez L, Saenz Valiente P. Once daily gentamicin dosing in neonates. Pediatric Infectious Disease Journal 1998;17(12):1169-71. [3386291]
4. Hagan R. Gentamicin in neonates: single vs multiple doses. Abstract book PSANZ 2002. 2002. [3386281]
5. Hayani KC, Hatzopoulos FK, Frank AL, Thummala MR, Hantsch MJ, Schatz BM, et al. Pharmacokinetics of once-daily dosing of gentamicin in neonates. Journal of Pediatrics 1997;131(1 Pt 1):76-80. [3386283]
6. Kosalaraksa P, Janthep P, Jirapradittha J, Taksaphan S, Kiatchoosakun P. Once versus twice daily dose of gentamicin therapy in Thai neonates. Journal of the Medical Association of Thailand 2004;87(4):372-6. [3386285]
7. Krishnan L, George SA. Gentamicin therapy in preterms: a comparison of two dosage regimens. Indian Pediatrics 1997;34(12):1075-80. [3386287]
8. Miron D, Steinfeld M, Hasanein J, Felszer C, Reich D. Tolerability of once-daily-dosing of intravenous gentamicin in preterm neonates born at 32-37 weeks of gestation. Harefuah 2003;142(6):413-5. [3386289]
9. Skopnik H, Wallraf R, Nies B, Troster K, Heimann G. Pharmacokinetics and antibacterial activity of daily gentamicin. Archives of Diseases in Childhood 1992;67(1 Spec No):57-61. [3386293]
10. Solomon R, Kuruvilla KA, Job V, Selvakumar R, Jeyaseelan L, Kanagasabapathy AS, et al. Randomized controlled trial of once vs. twice daily gentamicin therapy in newborn. Indian Pediatrics 1999;36(2):133-7. [3386295]
11. Thureen PJ, Reiter PD, Gresores A, Stolpman NM, Kawato K, Hall DM. Once- versus twice-daily gentamicin dosing in neonates >=34 weeks' gestation: cost-effectiveness analyses. Pediatrics 1999;103(3):594-8. [3386297]
12. Alsaedi SA. Once daily gentamicin dosing in full term neonates. Saudi Medical Journal 2003;24(9):978-81. [3386299]
13. Alshaikh B, Dersch-Mills D, Taylor R, Akierman AR, Yusuf K. Extended interval dosing of gentamicin in premature neonates ≤ 2-week gestation. Acta Paediatrica 2012;101(11):1134-9. [3386301; PUBMED: 22897142]
14. Davies MW, Cartwright DW. Gentamicin dosage intervals in neonates: longer dosage interval--less toxicity. Journal of Paediatrics and Child Health 1998;34(6):577-80. [3386303]
15. English M, Mohammed S, Ross A, Ndirangu S, Kokwaro G, Shann F, et al. A randomised, controlled trial of once daily and multi-dose daily gentamicin in young Kenyan infants. Archives Of Disease in Childhood 2004;89(7):665-9. [3386305]
16. Fjalstad JW, Laukli E, van den Anker JN, Klingenberg C. High-dose gentamicin in newborn infant: is it safe?. European Journal of Paediatrics 2014;173(4):489-95. [3386307; PUBMED: 10717501]
17. Gonzalez Santacruz M, Tarazona Fargueta JL, Ferrandis Rodriguez O, Tapia Collados C, Jimenez Cobo B. Comparison of two gentamicin dosing schedules in the newborn. Anales de pediatría 2008;68(6):581-8. [3386309]
18. Hagen I, Oymer K. Pharmacological differences between once and twice daily gentamicin dosage in newborns with suspected sepsis. Pharmacy World and Science 2009;31(1):18-23. [3386311]
19. Hansen A, Forbes P, Arnold A, O'Rourke E. Once-daily gentamicin dosing for the preterm and term newborn: proposal for a simple regimen that achieves target levels. Journal of Perinatology 2003;23(8):635-9. [3386313]
20. Hiltron AE, Sun Y, Scarpace SB. Accuracy of empiric gentamicin dosing guidelines in neonates. The Journal of Pediatric Pharmacology and Therapeutics 2010;15(4):264-73. [3386315; PUBMED: 22477814]
21. Hoff DS, Wilcox RA, Tollefson LM, Lipnik PG, Commers AR, Liu M. Pharmacokinetic outcomes of a simplified, weight-based, extended-interval gentamicin dosing protocol in critically ill neonates. Pharmacotherapy 2009;29(11):1297-305. [3386317; PUBMED: 19857147]
22. Hossain MM, Chowdhury NA, Shirin MS, Saha SK, Miller-Bell M, Edwards D, et al. Simplified dosing of gentamicin for treatment of sepsis in Bangladeshi neonates. Journal of Health, Population and Nutrition 2009;27(5):640-5. [3386319; PUBMED: 19902799]
23. Isemann BT, Kotagal UR, Mashni SM, Luckhaupt EJ, Johnson CJ. Optimal gentamicin therapy in preterm neonates includes loading doses and early monitoring. Therapeutic Drug Monitoring 1996;18(5):549-55. [3386321]
24. Kaspers GJ, Teunissen PC, Holl H. Gentamicin administration in newborns: once daily. Nederlands Tijdschrift voor Geneeskunde 1998;142(11):583-6. [3386323]
25. Krishnamoorthy SS, Nair A, Furness J, Sanderson J. Gentamicin use in neonates: should we have a change of practice?. Scottish Medical Journal 2013;58(4):241-5. [3386325; PUBMED: 24215045]
26. Lanao JM, Calvo MV, Mesa JA, Martin-Suarez A, Carbajosa MT, Miguelez F, et al. Pharmacokinetic basis for the use of extended interval dosage regimens of gentamicin in neonates. Journal of Antimicrobial Chemotherapy 2004;54(1):193-8. [3386327]
27. Low YS, Tan SL, Wan AS. Extended-interval gentamicin dosing in achieving therapeutic concentrations in Malaysian neonates. Journal of Pediatric Pharmacology and Therapeutics 2015;20(2):119-25. [3386329; PUBMED: 25964729]
28. Lundergan FS, Glasscock GF, Kim EH, Cohen RS. Once-daily gentamicin dosing in newborn infants. Pediatrics 1999;103(6 Pt 1):1228-34. [3386331]
29. Martinkova J, Pokorna P, Zahora J, Chladek J, Vobruba V, Selke-Krulichova I, et al. 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 2010;32(14):2400-14. [3386333; PUBMED: 21353108]
30. Mercado MC, Brodsky NL, McGuire MK, Hurt H. Extended interval dosing of gentamicin in preterm infants. American Journal of Perinatology 2004;21(2):73-7. [3386335]
31. Rastogi A, Agarwal G, Pyati S, Pildes RS. Comparison of two gentamicin dosing schedules in very low birth weight infants. Pediatric Infectious Disease Journal 2002;21(3):234-40. [3386337]
32. Semchuk W, Shevchuk YM, Sankaran K, Wallace SM. Prospective, randomized, controlled evaluation of a gentamicin loading dose in neonates. Biology of the Neonate 1995;67(1):13-20. [3386339]
33. Serane TV, Zengeya S, Penford G, Cooke J, Khanna G, McGregor-Colman E. Once daily dose gentamicin in neonates - is our dosing correct?. Acta Paediatrica 2009;98(7):1100-5. [3386341]
34. Skopnik H, Heimann G. Once daily aminoglycoside dosing in full term neonates. Pediatric Infectious Disease Journal 1995;14(1):71-2. [3386343]
35. Stickland MD, Kirkpatrick CM, Begg EJ, Duffull SB, Oddie SJ, Darlow BA. An extended interval dosing method for gentamicin in neonates. Journal of Antimicrobial Chemotherapy 2001;48(6):887-93. [3386345]
36. Tantiprabha W, Juntarakana S, Chotinaruemol S, Rojanasthien N. Efficacy and safety of gentamicin by interval and intravenous dosage adjustment based on the gestational age in Thai neonates. Journal of the Medical Association of Thailand 2007;90(12):2601-7. [3386347]
37. Thingvoll ES, Guillet R, Caserta M, Dicenzo R. Observational trial of a 48-hour gentamicin dosing regimen derived from Monte Carlo simulations in infants born at less than 28 weeks' gestation. Journal of Pediatrics 2008;153(4):530-4. [3386349]
38. Tiwari S, Rehan HS, Chandra J, Mathur NN, Singh V. Efficacy and safety of a single daily dose of gentamicin in hospitalized Indian children: a quasi-randomized trial. Journal of Antimicrobial Chemotherapy 2009;64(5):1096-101. [3386351]
39. Yeung MY, Smyth JP. Targeting gentamicin concentrations in babies: the younger the baby, the larger the loading dose and the longer the dose interval. Australian Journal of Hospital Pharmacy 2000;30(3):98-101. [3386353]
40. Ali MZ, Goetz MB. A meta-analysis of the relative efficacy and toxicity of single daily dosing versus multiple daily dosing of aminoglycosides. Clinical Infectious Diseases 1997;24(5):796-809. [PUBMED: 9142772]
41. Aperia A, Broberger O, Elinder G, Herin P, Zetterstrom R. Postnatal development of renal function in pre-term and full-term infants. Acta Paediatrica Scandinavia 1981;70(2):183-7.
42. Bailey TC, Little JR, Littenberg B, Reichley RM, Dunagan WC. A meta-analysis of extended-interval dosing versus multiple daily dosing of aminoglycosides. Clinical Infectious Diseases 1997;24(5):786-95.
43. Bajaj M, Palmer K. Gentamicin usage in newborns--a simple and practical regime. Pharmacy World & Science 2004;26(4):242-4.
44. Barza M, Ioannidis JP, Cappelleri JC, Lau J. Single or multiple daily doses of aminoglycosides: a meta-analysis. BMJ 1996;312(7027):338-45.
45. Beaubien AR, Ormsby E, Bayne A, Carrier K, Crossfield G, Downes M, et al. Evidence that amikacin ototoxicity is related to total perilymph area under the concentration-time curve regardless of concentration. Antimicrobial Agents and Chemotherapy 1991;35(6):1070-4.
46. Begg EJ, Vella-Brincat JW, Robertshawe B, McMurtrie MJ, Kirkptrick CM, Darlow B. Eight years' experience of an extended-interval dosing protocol for gentamicin in neonates. Journal of Antimicrobial Chemotherapy 2009;63(5):1043-9.
47. Blackburn ST. Renal function in the neonate. Journal of Perinatal and Neonatal Nursing 1994;8(1):37-47. [PUBMED: 8006805]
48. Chambers HF. The aminoglycosides. Goodman and Gillman's The pharmacological basis of therapeutics. McGraw-Hill Professional, 2001.
49. Chattopadhyay B. Newborns and gentamicin--how much and how often?. Journal of Antimicrobial Chemotherapy 2002;49(1):13-6.
50. Chuck SK, Raber SR, Rodvold KA, Areff D. National survey of extended-interval aminoglycoside dosing. Clinical Infectious Diseases 2000;30(3):433-9.
51. Contopoulos-Ioannidis DG, Giotis ND, Baliatsa DV, Ioannidis JP. Extended-interval aminoglycoside administration for children: a meta-analysis. Pediatrics 2004;114(1):e111-8.
52. Coscia A, Maiorca D, Martano C, Rossi C, Appino I, Cirina P, et al. Use of netilmicin once or twice daily in preterm newborns: evaluation of nephrotoxicity by urinary alpha 1-microglobulin and retinol binding protein. Journal of Chemotherapy 2008;20(3):324-6.
53. Craig WA. Once-daily versus multiple-daily dosing of aminoglycosides. Journal of Chemotherapy 1995;7 suppl 2:47-52.
54. Darmstadt GL, Hossain MM, Jana AK, Saha SK, Choi Y, Sridhar S, et al. Determination of extended-interval gentamicin dosing for neonatal patients in developing countries. Pediatric Infectious Disease Journal 2007;26(6):501-7.
55. Darmstadt GL, Miller-Bell M, Batra M, Law P, Law K. Extended-interval dosing of gentamicin for treatment of neonatal sepsis in developed and developing countries. Journal of Health, Population, and Nutrition 2008;26:163-82.
56. El-Barbary MN, Ismail RIH, Ibrahim AAA. Gentamicin extended interval regimen and ototoxicity in neonates. International Journal of Pediatric Otorhinolaryngology 2015;79(8):1294-8. [PUBMED: 26071016]
57. Fuchs A, Guidi M, Giannoni E, Werner D, Buclin T, Widmer N, et al. Population pharmacokinetic study of gentamicin in a large cohort of premature and term neonates. British Journal of Clinical Pharmacology 2014;78(5):1090-101. [PUBMED: 24938850]
58. Fullas F, Padomek MT, Thieman CJ, Van Gorp AE. Comparative evaluation of six extended-interval gentamicin dosing regimens in premature and full-term neonates. American Journal of Health-System Pharmacy 2011;68(1):52-6. [PUBMED: 21164066]
59. Gallini F, Maggio L, Romagnoli C, Marrocco G, Tortorolo G. Progression of renal function in preterm neonates with gestational age < or = 32 weeks. Pediatric Nephrology 2000;15(1-2):119-24.
60. García B, Barcia E, Pérez F, Molina IT. Population pharmacokinetics of gentamicin in premature newborns. Journal of Antimicrobial Chemotherapy 2006;58(2):372-9. [PUBMED: 16782742]
61. Giuliano RA, Verpooten GA, Verbist L, Wedeen RP, De Broe ME. In vivo uptake kinetics of aminoglycosides in the kidney cortex of rats. Journal of Pharmacology and Experimental Therapeutics 1986;236(2):470-5.
62. McMaster University. GRADEpro [www.gradepro.org]. McMaster University, 2014.
63. Guyatt G, Oxman AD, Akl EA, Kunz R, Vist G, Brozek J, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. Journal of Clinical Epidemiology 2011;64(4):383-94. [PUBMED: 21195583]
64. Guyatt GH, Oxman AD, Vist G, Kunz R, Brozek J, Alonso-Coello P, et al. GRADE guidelines: 4. Rating the quality of evidence--study limitations (risk of bias). Journal of Clinical Epidemiology 2011;64(4):407-15. [PUBMED: 21247734]
65. Guyatt GH, Oxman AD, Kunz R, Brozek J, Alonso-Coello P, Rind D, et al. GRADE guidelines: 6. Rating the quality of evidence--imprecision. Journal of Clinical Epidemiology 2011;64(12):1283-93. [PUBMED: 21839614]
66. Guyatt GH, Oxman AD, Kunz R, Woodcock J, Brozek J, Helfand M, et al. GRADE guidelines: 7. Rating the quality of evidence--inconsistency. Journal of Clinical Epidemiology 2011;64(12):1294-302. [PUBMED: 21803546]
67. Guyatt GH, Oxman AD, Kunz R, Woodcock J, Brozek J, Helfand M, et al. GRADE guidelines: 8. Rating the quality of evidence--indirectness. Journal of Clinical Epidemiology 2011;64(12):1303-10. [PUBMED: 21802903]
68. Hatala R, Dinh TT, Cook DJ. Single daily dosing of aminoglycosides in immunocompromised adults: a systematic review. Clinical Infectious Diseases 1997;24(5):810-5.
69. Hitt CM, Klepser ME, Nightingale CH, Quintiliani R, Nicolau DP. Pharmacoeconomic impact of once-daily aminoglycoside administration. Pharmacotherapy 1997;17(4):810-4.
70. Kahlmeter G, Dahlager JI. Aminoglycoside toxicity - a review of clinical studies published between 1975 and 1982. Journal of Antimicrobial Chemotherapy 1984;13 Suppl A:9-22.
71. Kent A, Turner MA, Sharland M, Heath PT. Aminoglycoside toxicity in neonates: something to worry about?. Expert Review of Anti-infective Therapy 2014;12(3):319-31. [PUBMED: 24455994]
72. Knoderer CA, Everett JA, Buss WF. Clinical issues surrounding once-daily aminoglycoside dosing in children. Pharmacotherapy 2003;23(1):44-56.
73. Kovarik JM, Hoepelman IM, Verhoef J. Once-daily aminoglycoside administration: new strategies for an old drug. European Journal of Clinical Microbiology & Infectious Diseases 1989;8(9):761-9.
74. König K, Lim A, Miller A, Saker S, Guy KJ, Barfield CP. Gentamicin trough levels using a simplified extended-interval dosing regimen in preterm and term newborn. European Journal of Pediatrics 2014;174(5):669-73. [PUBMED: 25388408]
75. Lacy MK, Nicolau DP, Nightingale CH, Quintiliani R. The pharmacodynamics of aminoglycosides. Clinical Infectious Diseases 1998;27(1):23-7.
76. Langlass TM, Mickle TR. Standard gentamicin dosage regimen in neonates. American Journal of Health-System Pharmacy 1999;56(5):440-3.
77. Lulic-Botica M, Sheer T, Edwards D, Thomas RL, Natarajan G. Impact of small-for-gestation age (SGA) status on gentamicin pharmacokinetics in neonates. Pediatric Pharmacology 2013;54(1):39-45. [PUBMED: 24122736]
78. McWilliams SJ, Antoine DJ, Sabbisetti V, Turner MA, Farragher T, Bonventre JV, et al. Mechanism-based urinary biomarkers to identify the potential for aminoglycoside-induced nephrotoxicity in premature neonates: a proof-of-concept study. PLoS One 2012;7(8):e43809. [PUBMED: 22937100]
79. Miron D. Once daily dosing of gentamicin in infants and children. Pediatric Infectious Disease Journal 2001;20(12):1169-73.
80. Munckhof WJ, Grayson ML, Turnidge JD. A meta-analysis of studies on the safety and efficacy of aminoglycosides given either once daily or as divided doses. Journal of Antimicrobial Chemotherapy 1996;37(4):645-63.
81. Nestaas E, Bangstad HJ, Sandvik L, Wathne KO. Aminoglycoside extended interval dosing in neonates is safe and effective: a meta-analysis. Archives of disease in childhood. Fetal and neonatal edition 2005;90(4):F294-300. [PUBMED: 15857879]
82. Nicolau DP, Wu AH, Finocchiaro S, Udeh E, Chow MS, Quintiliani R, et al. Once-daily aminoglycoside dosing: impact on requests and costs for therapeutic drug monitoring. Therapeutic Drug Monitoring 1996;18(3):263-6.
83. Nielsen EI, Sandström M, Honoré PH, Ewald U, Friberg LE. Developmental pharmacokinetics of gentamicin in preterm and term neonates: population modelling of a prospective study. Clinical Pharmacokinetics 2009;48(4):253-63.
84. Olsen KM, Rudis MI, Rebuck JA, Hara J, Gelmont D, Mehdian R, Nelson C, Rupp ME. Effect of once-daily dosing vs. multiple daily dosing of tobramycin on enzyme markers of nephrotoxicity. Critical Care Medicine 2004;32:1678-82.
85. Pacifici GM. Clinical pharmacokinetics of aminoglycosides in the neonate: a review. European Journal of Clinical Pharmacology 2009;65:419-27.
86. Schünemann H, Brozek J, Guyatt G, Oxman A, editors. GRADE Working Group. GRADE handbook for grading quality of evidence and strength of recommendations. Available from www.guidelinedevelopment.org/handbook updated October 2013.
87. Setiabudy R, Suwento R, Rundjan L, Yasin FH, Louisa M, Dwijayanti A, et al. Lack of relationship between the serum concentration of aminoglycosides and ototoxicity in neonates. International Journal of Clinical Pharmacology and Therapeutics 2013;51(5):401-6. [PUBMED: 23557866]
88. Sonntag J, Prankel B, Waltz S. Serum creatinine concentration, urinary creatinine excretion and creatinine clearance during the first 9 weeks in preterm infants with a birth weight below 1500 g. European Journal of Pediatrics 1996;155(9):815-9.
89. Stoll BJ, Gordon T, Korones SB, Shankaran S, Tyson JE, Bauer CR, et al. Early-onset sepsis in very low birth weight neonates: a report from the National Institute of Child Health and Human Development Neonatal Research Network. Journal of Pediatrics 1996;129(1):72-80.
90. Stoll BJ, Gordon T, Korones SB, Shankaran S, Tyson JE, Bauer CR, et al. Late-onset sepsis in very low birth weight neonates: a report from the National Institute of Child Health and Human Development Neonatal Research Network. Journal of Pediatrics 1996;129(1):63-71.
91. Swan SK. Aminoglycoside nephrotoxicity. Seminars in Nephrology 1997;17(1):27-33.
92. Touw DJ, Westerman EM, Sprij AJ. Therapeutic drug monitoring of aminoglycosides in neonates. Clinical Pharmacokinetics 2009;48(2):71-88.
93. Valitalo PAJ, van den Anker JN, Allegaert K, de Cock RFW, de Hoong M, Simons SHP, et al. Novel model-based dosing guidelines for gentamicin and tobramycin in preterm and term neonates. Journal of Antimicrobial Chemotherapy 2015;70(7):2074-7. [PUBMED: 25766737]
94. Vanpée M, Ergander U, Herin P, Aperia A. Renal function in sick, very low-birth-weight infants. Acta Paediatrica 1993;82(9):714-8.
95. Verpooten GA, Giuliano RA, Verbist L, Eestermans G, De Broe ME. Once-daily dosing decreases renal accumulation of gentamicin and netilmicin. Clinical Pharmacology and Therapeutics 1989;45(1):22-7.
96. Rao SC, Ahmed M, Hagan R. One dose per day compared to multiple doses per day of gentamicin for treatment of suspected or proven sepsis in neonates. Cochrane Database of Systematic Reviews 2006, Issue 1. [DOI: 10.1002/14651858.CD005091.pub2]