Aerosolized Plus Intravenous Colistin Compared With Intravenous Colistin for Adjunctive Treatment of Ventilator-associated Pneumonia Due to Pandrugs-resistant Acinetobacter Baumannii in the Neonates: Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Number of Patients With Death
研究概览
简要总结
This study is planned to compare the clinical efficacy and safety of aerosolized plus intravenous colistin vs. intravenous colistin as adjunctive therapy for the treatment of ventilator-associated pneumonia (VAP) due to pandrugs-resistant (PDR) Acinetobacter baumannii in the neonates.
详细描述
This study will evaluate the neonates with VAP due to PDR-Acinetobacter baumannii who receive aerosolized plus intravenous colistin compare with intravenous colistin as adjunctive therapy. The efficacy and safety after study will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates who are admitted to the neonatal intensive care unit, Hat Yai Hospital during the study period.
- •Neonates who were complicated with VAP due to PDR-Acinetobacter baumannii susceptible to colistin (by minimal inhibitory concentration (MIC) < 2 mcg/dL).
排除标准
- •Neonates who have a major anomaly or chromosomal abnormality.
- •Neonates who receive colistin prior 7 days prior to study.
- •Neonates who have a significant renal dysfunction defined as a serum creatinine (SCr) >1.5 mg/dL or a decrease in urine output to < 1 mL/kg/h;
研究组 & 干预措施
Aerosolized plus intravenous colistin
Neonates with VAP due to PDR-A. baumannii who receive aerosolized colistin (4 mg/kg/dose twice daily) plus intravenous colistin (3.5 mg/kg/dose twice daily)
干预措施: Aerosolized plus intravenous colistin (Drug)
Intravenous colistin
Neonates with VAP due to PDR-A. baumannii who receive only intravenous colistin (3.5 mg/kg/dose twice daily)
干预措施: Intravenous colistin (Drug)
结局指标
主要结局
Number of Patients With Death
时间窗: Through study completion, an average of 2 weeks
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Number of Patients With Failure
时间窗: Through study completion, an average of 2 weeks
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Number of Patients With Cure
时间窗: Through study completion, an average of 2 weeks
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
Number of Patients With Improved
时间窗: Through study completion, an average of 2 weeks
Clinical outcome is classified in 4 categories: Cure, Improved, Failure, and Death
次要结局
- Number of Patients With Eradication(Through study completion, an average of 2 weeks)
- Number of Patients With Superinfection(Through study completion, an average of 2 weeks)
- Number of Patients With Adverse Events That Are Related to Study Drug(Through study completion, an average of 4 weeks)
- Number of Patients With Persistence(Through study completion, an average of 2 weeks)
研究者
Dr. Narongsak Nakwan
Head of Division of Neonatalogy, Department of Pediatrics, Hat Yai Hospital
Hat Yai Medical Education Center