PACTR202301805346465尚未招募2 期
A novel 4-month pan-TB regimen targeting both Host and Microbe (panTB-HM)
The Aurum Institue NPC0 个研究点目标入组 352 人开始时间: 2022年12月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 352
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
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •1.Aged 18 to 65 years
- •2.Willing and able to provide signed written consent prior to undertaking any trial-related procedures.
- •a.Or, in the case of illiteracy, witnessed oral consent
- •3.Body weight (in light clothing without shoes) between 30 and 90 kg.
- •4.Radiographic evidence of pulmonary tuberculosis
- •5.Positive Xpert TB/RIF (original or Ultra) for MTB
- •6.RIF susceptibility diagnosed by Xpert TB/RIF, with subsequent culture confirmation
- •7.If sexually active, willing to use an effective contraceptive method for the duration of tuberculosis treatment
- •8.HIV-1 seronegative, or if HIV-1 seropositive, CD4 T cell count =100/µl and either receiving ART or willing to start ART during study participation
- •9.SARS-CoV-2 PCR or antigen test negative, or if positive, either fully vaccinated against Covid-19 or with D-dimer <0.8 ?g/ml
- •10.Willing to adhere to a diet excluding tyramine-rich foods (certain mold-ripened cheeses and cured meats), and to avoid eating grapefruits and pomelos
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
- •2.Current or imminent (within 24 hr) treatment for malaria.
- •3.Pregnant or nursing
- •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 spondylitis, 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.
- •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.Prior 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.History of unstable Diabetes Mellitus requiring hospitalization for hyper- or hypo-glycaemia within the past year prior to start of screening.
- •12.Use of systemic corticosteroids within the past 28 days.
- •13.Patients requiring treatment with medications not compatible with rifampin, such as HIV-1 protease inhibitors
- •14.Patients requiring treatment with antidepressants, including MAO inhibitors and SSRIs.
- •15.Subjects with any of the following abnormal laboratory values:
- •a.HBsAg positive
- •b.creatinine >2 mg/dL
- •c.hemoglobin <8 g/dL
- •d.platelets <100x109 cells/L
- •e.serum potassium <3.5 mM/L
- •f.alanine aminotransferase (ALT) =2.0 x ULN
- •g.alkaline phosphatase (AP) >5.0 x ULN
- •h.total bilirubin >1.5 mg/dL
- •i.random blood glucose >200 mg/dL
- •NB: All of the inclusion and none of the exclusion criteria must be met
研究者
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