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临床试验/NCT01624324
NCT01624324Unknown不适用

Aminoglycoside Plasma Level Measurement in Neonates With Infection

Indonesia University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
1

研究概览

简要总结

The aim of this study is to determine whether the plasma concentration of aminoglycoside in Indonesia neonates with infection are within safe and effective range and its association with cochlear toxicity and nephrotoxicity.

详细描述

Aminoglycosides are toxic antibiotics, but they are urgently needed to treat newborns with severe infections. Aminoglycosides are well known for their nephrotoxicity and ototoxicity, meanwhile the renal function of the newborns is not yet fully developed.The aminoglycoside dosage currently applied in Indonesia is derived from studies done in Caucasian populations. The safety and efficacy of this dosage regimen, however, have never been evaluated till 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 nephrotoxicity and ototoxicity in newborns in the Cipto Mangunkusumo Hospital treated with gentamicin or amikacin in relation to their trough serum concentration. The serum level of gentamicin and amikacin is assumed to be safe if the trough serum concentrations are < 2 mcg/mL and effective if its 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 nephrotoxicity was assessed by measuring the level of kidney injury molecule-1 in urine while the ototoxicity was assessed by Distortion Product Otoacoustic Emission (DPOE) instrument.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • neonates with infection treated with gentamicin or amikacin

排除标准

  • neonates who hypersensitive to gentamicin and amikacin
  • neonates who also treated with other nephrotoxic drugs (vancomycin, furosemide, amphotericin B, meropenem)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rianto Setiabudy

Prof. Dr. dr. SpFK(K)

Indonesia University

研究点 (1)

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