CTRI/2023/08/056974尚未招募Unknown
Evaluation of safety and efficacy of delamanid in patients with multidrug-resistant tuberculosis (MDR-TB) - NA
Jawaharlal Nehru Medical College Aligarh Muslim University Aligarh0 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
- Interventional
入排标准
入选标准
- •1.Patients capable of giving written informed consent
- •2.Diagnosis of MDR-TB on CBNAAT or sputum culture
- •3.Chest radiograph diagnostic of TB
- •4.Positive sputum sample
- •5.Normal ECG
排除标准
- •1.Serum albumin: < 2.8g/dL
- •2.Patient on drug of strong inducer of CYP3A4 enzyme
- •3.Severe renal impairment
- •4.Moderate or severe hepatic impairment
- •5.Hypersensitivity to drug
- •6.Infection by Mycobacterial species other than those of the mycobacterium complex
- •7.Abnormal ECG and QTc
- •9.Body mass index (BMI) < 16 kg/m2
- •10.Karnofsky score < 50%
- •11.Significant metabolic, gastrointestinal, neurological, psychiatric, or endocrine diseases, active malignancy
- •12.History of alcohol abuse
- •13.Pregnant, breast-feeding or planning to conceive
- •14.Previous exposure to Delamanid
研究者
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