A RANDOMIZED CONTROL TRIAL TO STUDY THE PHARMACOKINETICS OF ONCE DAILY INTRAVENOUS VERSUS INTRAMUSCULAR GENTAMICIN IN INFANTS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Peak and Trough serum gentamicin concentrations (SGCs) post single dose of intravenous gentamicin and intramuscular gentamicin injections.
研究概览
简要总结
Gentamicin is frequently used for the treatment of serious bacterial infections in neonates and infants. Gentamicin can be administered either intravenously or intramuscularly. Intravenous administration of gentamicin has 100% bioavailability and achieves the peak serum concentration within 30 minutes of its administration but is associated with iatrogenic complications like infection,phlebitis,extravasation,air embolism,hemorrhageand hematoma. In addition, intravenous therapy requires skilled health workers viz nurse to administer it. On the other hand, intramuscular administration of gentamicin has less chance of such iatrogenic complications and is also convenient to administer.However, there is limited data on the pharmacokinetics of intramuscular gentamicin in infants.
It was assumed that single daily dose of intramuscular gentamicin may have comparable serum peak and trough levels with that following intravenous administration for treating serious bacterial infections in infants. To further establish this, present study was conducted to compare the pharmacokinetics of once daily intramuscular gentamicin versus once daily intravenous gentamicin in young infants suffering from serious bacterial infections. The findings of this study suggested that IV and IM gentamicin have comparable pharmacokinetics (peak and trough concentrations). Therefore, health centres in developing countries where there are limited available resources including trained health care professionals to administer intravenous injection, intramuscular route to administer gentamicin in young infants should be preferred.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Day(s) 至 6.00 Month(s)（—）
- 性别
- All
入选标准
- •All infants of age less than or equal to 6 months admitted to a Paediatric unit of Kalawati Saran Children Hospital, New Delhi with suspected or confirmed infections considered suitable for gentamicin therapy such as, i.
- •Suspected Gram-negative sepsis, ii.
- •Infections like acute enteritis, pneumonia, meningitis and septic arthritis, and iii.
- •Urinary tract infection (UTI).
排除标准
- •Age greator than 6 months ii.
- •Abnormal renal functions (serum urea and creatinine).
- •Earlier diagnosed cases of impaired internal ear function or deafness.
- •Severely ill patients or those with life-threatening infections.
结局指标
主要结局
Peak and Trough serum gentamicin concentrations (SGCs) post single dose of intravenous gentamicin and intramuscular gentamicin injections.
时间窗: After 30 minutes and 60 minutes of IV and IM administration of gentamicin respectively, to determine serum peak levels of gentamicin. To estimate trough serum gentamicin levels after 18 hours of administration of gentamicin by either route.
次要结局
- No secondary Outcomes(Not Applicable)