NCT07227779招募中2 期
A PHASE 2 NOVEL ANTIMICROBIAL COMBINATION THERAPY TO TREAT TUBERCULOUS MENINGITIS
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 312
- 试验地点
- 3
- 主要终点
- Hierarchical composite endpoint (survival + functional status)
研究概览
简要总结
This two-stage study will compare consented research participants with tuberculous meningitis receiving BPaLMZ to controls receiving SOC of rifampicin (R), isoniazid (H), pyrazinamide (Z), and ethambutol (E), known as RHZE.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First Episode definite or probable TBM with physician intent to treat
- •Age ≥18 years
- •Provision of Informed Consent by participant or surrogate
- •Living with HIV
- •Weight > 35kg, estimate or measured
排除标准
- •Additional active and confirmed CNS infection
- •Known rifampicin-resistant TB
- •Allergy or contraindication to a study medicine
- •More than 5 doses of any TB therapy received within the previous 14 days
- •Presence of jaundice, known liver cirrhosis, elevated ALT or AST >3x ULN, or total bilirubin >2x ULN
- •Estimated Glomerular Filtration Rate <30 ml/min/1.73m2
- •Significant cardiac comorbidity, heart failure, arrhythmia, or QTc >450 ms
- •Pregnancy or Breastfeeding
- •Cryptococcal antigen positivity in blood
- •Condition which makes participation not in the participant's best interest
研究组 & 干预措施
Standard of Care Regimen
No Intervention
rifampicin, isoniazid, pyrazinamide, ethambutol (RHZE) therapy
BPaLMZ Regimen
Experimental
bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide (BPaLMZ)
干预措施: BPaLMZ Regimen (Drug)
结局指标
主要结局
Hierarchical composite endpoint (survival + functional status)
时间窗: 24 Weeks
Hierarchical composite endpoint of survival and modified Rankin score (0-6 scale) assessed by Win Ratio
Time to Death
时间窗: 24 Weeks
Functional Status
时间窗: 24 Weeks
Modified Rankin score
次要结局
- Serious adverse events (SAE)(28 weeks)
- Clinical Adverse Events(28 weeks)
- Laboratory abnormalities(28 weeks)
- Neuropathy(28 weeks)
- Drug induced liver injury(28 weeks)
- Change in CSF inflammatory markers(14 days)
- Additional corticosteroids use(24 weeks)
- Modified Rankin Scale(24 weeks)
- Change in blood inflammatory markers(7 days)
- Quantitative neurocognitive performance Z-score(24 weeks)
- Change in PCR cycle threshold (Ct) value in CSF(14 days)
- Altered Mental Status over time(10 days)
- Change in CSF glcuose(14 days)
- Change in serum C-reactive protein(7 days)
研究者
David Boulware
McKnight Distinguished Professor
University of Minnesota
研究点 (3)
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