PACTR202407655325739尚未招募3 期
Confirmatory Trial of Adjunctive N-acetylcysteine to Prevent and/or Treat Post Tuberculosis Lung Disease (NAC-PTLD)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 484
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
- 年龄范围
- 13 Year(s) 至 18 Year(s)（—）
- 性别
- All
入选标准
- •1. Persons aged 18 to 65 years
- •2. Willing and able to provide signed written consent or witnessed oral consent with thumbprint
- •in the case of illiteracy, prior to undertaking any trial-related procedures.
- •3. Body weight (in light clothing without shoes) between 30 and 90 kg.
- •4. Xpert TB/RIF OR Ultra showing RIF-S-MTB, with subsequent confirmation of MTB by culture.
- •5. Chest radiograph meeting criteria for moderate or far advanced pulmonary tuberculosis 1
- •6. FEV1 =65% of predicted based on age, height, sex, and race
- •7. If female, of child-bearing potential and sexually active, willing to use an effective contraceptive
- •method for the duration of study participation
- •8. HIV-1/2 seronegative, OR if seropositive, CD4 T cell count =100/µl AND willing to either continue
- •or start ART during study participation
- •9. Negative SARS-CoV-2 Ag, or if positive, with D-dimer <1.0 mg/
排除标准
- •1. Any condition for which participation in the trial, as judged by the investigator, could compromise
- •the well-being of the subject or prevent, limit or confound protocol specified assessments,
- •such as pneumothorax or clinically significant pleural effusion.
- •2. Current or imminent (within 24 hr) treatment for malaria.
- •3. Pregnancy or breastfeeding
- •4. Is critically ill, and in the judgment of the investigator has a diagnosis likely to result in death
- •during the trial or the follow-up period.
- •5. TB meningitis or other forms of severe tuberculosis with high risk of a poor outcome as judged
- •by the investigator.
- •6. History of allergy or hypersensitivity to any of the trial therapies or related substances, including
- •known allergy or suspected hypersensitivity to rifampin.
- •7. Having participated in other clinical trials with investigational agents within 8 weeks prior to
- •trial start or currently enrolled in an investigational trial.
- •8. No more than 5 days treatment for the current TB episode, and no other TB treatment in the
- •preceding 6 months
- •9. Angina pectoris requiring treatment with nitroglycerin or other nitrates
- •10. Cardiac arrhythmia requiring medication, or any clinically significant ECG abnormality, in the
- •opinion of the investigator
- •11. Random blood glucose >140 mg/dL (7.8mmol/L), or history of unstable Diabetes Mellitus
- •which required hospitalization for hyper- or hypoglycaemia within the past year prior to start
- •of screening.
- •12. Use of systemic corticosteroids within the past 28 days, or likely to require systemic corticosteroids
- •for another medical condition during the study period.
- •13. Patients requiring treatment with medications not compatible with rifampin, such as HIV protease
- •14. Subjects with any of the following abnormal laboratory values:a. creatinine >2 mg/dL (176.84umol/L)
- •b. haemoglobin <8 g/dL
- •c. platelets <100x109 cells/L
- •d. serum potassium <3.5 mmol/l
- •e. aspartate aminotransferase (AST) =2.0 x ULN
- •f. alkaline phosphatase (AP) >5.0 x ULN
- •g. total bilirubin >1.5 mg/dL (25.65umol/L)
- •h. positive HbsAg
研究者
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