CTRI/2023/04/051382尚未招募Unknown
Clinical efficacy and pharmacokinetics of colistimethate sodium in critically ill paediatric patients admitted in a tertiary care teaching hospital in India: a prospective longitudinal observational pilot study
AIIMS RAIPUR0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.Age 1 months- 15 years of either sex
- •2.Suspected or culture proven MDR-GNB infection requiring CMS administration as per the decision of treating Paediatrician.
排除标准
- •1.Patients with average body weight < 4.55kg.
- •2.Patients who have received CMS before study (time frame: within last 7 days)
- •3.Administration of CMS through other routes (inhalational/intrathecal/intraventricular)
- •4.Patients with renal impairment manifested as serum creatinine above the upper limit of age ( >0.4 mg/dl for infants, >0.7 mg/dl for children, >1 mg/dl for adolescents)
- •5.Parental refusal of consent.
- •6.Cystic fibrosis
- •7.History of hypersensitivity to colistin
- •8.Family or personal history of myasthenia gravis
- •9.Refractory shock or other illness with an expectative life < 48 hrs.
- •10.Positive serology for HBV, HCV and HIV
- •11. Concomitant use of other nephrotoxic drugs and drugs found to interact with colistin as per FDA guidelines like aminoglycosides, polymyxin, Curariform muscle relaxants (e.g., tubocurarine) and other drugs, including ether, succinylcholine, gallamine, decamethonium, sodium citrate, Sodium cephalothin.
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