Determination of Pharmacokinetics and AntimycobacterialActivity of Bedaqualine, Delamanid,Clofazimine and Linezolid in Children and Adolescentswith Drug Resistant Tuberculosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To determine the highest AUC for Bedaqualine, Delamanid, Clofazimine,and Linezolid that is both safe and tolerable.
研究概览
简要总结
Data on drug-resistant TB (DR-TB) in children are limited. DR-TB is a growing public health concern for children and worldwide, ~25,000–32,000 children develop MDR-TB each year, of whom <5% receive treatment. One of the reasons is the inadequate dosing recommendations for existing therapies in children.
Novelty: This study will provide novel PK data for appropriate drug dosing recommendations for newer anti-TB drugs to be used for the treatment of DR-TB in children and adolescents.
Objectives:
Primary: Evaluate the pharmacokinetic activity of Bedaqualine, Delamanid, Clofazimine, Linezolid in children and adolescents (3 years to 18 years of age) diagnosed with confirmed or probable drug-resistant tuberculosis (DR-TB).
Secondary: To evaluate the safety and tolerability of Bedaqualine, Delamanid, Clofazimine, and Linezolid in children and adolescents To describe the clinical outcome of children and adolescents with DR-TB
Methods: This will be a multi-centre, single-arm study where, 100 children and adolescents aged from 3 to 18 years with confirmed or probable DR-TB, including pre-XDR-TB or XDRTB, or MDR-TB will be included. These children will receive age/weight appropriate dose of newer drugs (Bedaqualine, Delamanid, Clofazimine, and Linezolid). Venous blood samples will be collected at 0, 1, 2, 3, 4, 6 and 8 hours post dose to quantify drug concentrations in plasma. Drug concentrations will be quantified using high performance liquid chromatography (HPLC) method which has been validated at ICMR-NIRT. Based on the plasma concentration of drugs obtained at different time points, certain pharmacokinetic variables (peak concentration, time to attain peak concentration, exposure, clearance, half-life) will be calculated by non-compartmental analysis.
Expected outcome: To determine the highest AUC for Bedaqualine, Delamanid, Clofazimine, and Linezolid that is both safe and tolerable.
Determine the proportion of children with adverse drug reactions to Bedaqualine, Delamanid, Clofazimine, and Linezolid
To identify factors associated with poor outcomes in children with DR-TB.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 3.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with drug resistant TB Receiving ATT regimen (for DR-TB) as prescribed by the treating paediatrician regularly for at least four weeks Should receive at least 3 drugs from Bedaqualine, Delamanid, Clofazimine, Linezolid.
排除标准
- •Caregivers / parents unwilling for hospitalisation and blood sampling.
结局指标
主要结局
To determine the highest AUC for Bedaqualine, Delamanid, Clofazimine,and Linezolid that is both safe and tolerable.
时间窗: at baseline
次要结局
- Determine the proportion of children with adverse drug reactions to Bedaqualine,(Delamanid, Clofazimine, & Linezolid)