CTRI/2024/07/070282尚未招募2 期
Evaluation of efficacy of add on oral levofloxacin in children with tubercular meningitis aged 6 months-18 years: A randomized controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Functional Status Scale
研究概览
简要总结
The RCT will evaluate the efficacy of add on oral levofloxacin during first 8 weeks of intensive phase of anti-tubercular therapy in improving the functional outcome at 12 weeks in pediatric patients with CNS tuberculosis aged 6 months- 18 years, as compared to standard care alone
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Month(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed cases of tubercular meningitis presenting to Department of Pediatrics, All India Institute Medical Sciences, Rishikesh with a diagnosis of TB meningitis as per Marais’ criteria and parents willing to comply with the study protocol and follow up.
排除标准
- •Pre-existing major chronic systemic illness including cardiovascular (arrhythmia, prolonged QTc interval or history of any arrhythmia), respiratory (chronic lung disease), gastrointestinal system (chronic liver disease) or chronic renal disease.
结局指标
主要结局
Functional Status Scale
时间窗: 12 weeks
次要结局
- Functional status scale(12 weeks)
- Pediatric Cerebral Performance Category(12 weeks)
- Survival(12 weeks)
- Duration of hospitalisation(At diagnosis)
- Number of patients with paradoxical reaction(within 12 weeks)
- Social quotient by Vineland Social Maturity Scale(12 weeks)
- Childhood Behavioural Checklist internalizing, externalizing and total score(12 weeks)
研究者
Achanya P
All India Institute of Medical Sciences, Rishikesh
研究点 (1)
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