Lack of a relationship between the serum concentration of aminoglycosides and ototoxicity in neonates

Int J Clin Pharmacol Ther. 2013 May;51(5):401-6. doi: 10.5414/CP201833.


Introduction: Gentamicin and the other aminoglycosides are toxic antibiotics, but they are urgently needed to treat newborns with neonatal sepsis. Aminoglycosides are well known for their nephrotoxicity and ototoxicity. The aminoglycoside dosage currently applied in Indonesia is derived from studies done in Caucasian populations. The safety and efficacy of this dosage regimen, however, has never been evaluated to date. The pharmacokinetic profile of drugs may vary between populations and this may be influenced by genetic factors, lifestyle, drug interactions, etc. The detection of aminoglycoside toxicity in newborns is usually problematic. The present study aims to know the proportion of ototoxicity in newborns in the Cipto Mangunkusumo Hospital treated with gentamicin or amikacin in relation to their trough serum concentration.

Methods: The serum level of gentamicin and amikacin were quantified using Liquid Chromatography Tandem Mass Spectrometry (LC-MSMS), and is assumed to be safe if the trough serum concentrations are < 2 mcg/ml and effective if it is between 5 - 12 mcg/ml. For amikacin the desired trough serum concentrations are < 10 mcg/ml and the peak is between 20 - 30 mcg/ml. The hearing function was assessed by Distortion Product Otoacoustic Emission (DPOAE) instrument. This study is registered with the NCT01624324.

Conclusion: Our study indicated that there was no relationship between aminoglycosides serum trough concentration and ototoxicity in neonates with neonatal sepsis.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Amikacin / blood*
  • Amikacin / pharmacokinetics
  • Amikacin / toxicity*
  • Anti-Bacterial Agents / blood*
  • Anti-Bacterial Agents / pharmacokinetics
  • Anti-Bacterial Agents / toxicity*
  • Chromatography, Liquid
  • Ear Diseases / chemically induced*
  • Ear Diseases / physiopathology
  • Female
  • Gentamicins / blood*
  • Gentamicins / pharmacokinetics
  • Gentamicins / toxicity*
  • Hearing / drug effects*
  • Hearing Tests
  • Humans
  • Indonesia
  • Infant
  • Infant, Newborn
  • Male
  • Otoacoustic Emissions, Spontaneous / drug effects
  • Risk Factors
  • Sepsis / blood
  • Sepsis / drug therapy*
  • Tandem Mass Spectrometry


  • Anti-Bacterial Agents
  • Gentamicins
  • Amikacin

Associated data