CTRI/2017/09/009693进行中（未招募）3 期
The evaluation of a standard treatment regimen of anti-tuberculosis drugs for patients with MDR-TBVersion 6.2 dated feb 2015 - STREAM
The international Union Against Tuberculosis and lung diseases0 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
- 3 期
- 状态
- 进行中（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
- •A patient will be eligible for randomisation into the study (Stage 2) if he/she:
- •1.Is willing and able to give informed consent to participate in the trial treatment and follow-up (signed or witnessed consent if the patient is illiterate)
- •2.Is aged 18 years or older
- •3.Has a positive AFB sputum smear result at screening (at least scanty), unless they are HIV positive in which case a positive GeneXpert result within four weeks prior to screening is sufficient
- •4.Has evidence of resistance to rifampicin either by line probe assay (Hain Genotype21), GeneXpert or culture-based drug susceptibility testing (DST), from a test performed at screening or from a test performed within the four weeks prior to screening
- •5.Is willing to have an HIV test and, if positive, is willing to be treated with ART in accordance with the national policies but excluding ART contraindicated for use with bedaquiline
- •6.Is willing to use effective contraception: pre-menopausal women or women whose last menstrual period was within the preceding year, who have not been sterilised must agree to use a barrier method or an intrauterine device unless their partner has had a vasectomy; men who have not had a vasectomy must agree to use condoms. In Stage 2 pre-menopausal women or women whose last menstrual period was within the preceding year, who have not been sterilised must agree to use two methods of contraception, for example a hormonal method and a barrier method.
- •7.Resides in the area and expected to remain for the duration of the study.
- •8.Has had a chest X-ray at that is compatible with a diagnosis of pulmonary TB (if such a chest X-ray taken within 4 weeks of randomisation is available, a repeat X-ray is not required)
- •9.Has normal K+, Mg2+ and corrected Ca2+ at screening.
排除标准
- •A patient will not be eligible for randomisation into the study ( Stage 2) if he/she:
- •1.Is infected with a strain of M. tuberculosis resistant to a second-line injectables by line probe assay (Hain Genotype21)
- •2.Is infected with a strain of M. tuberculosis resistant to a fluoroquinolone by line probe assay (Hain Genotype21)
- •3.Has tuberculous meningitis or bone and joint tuberculosis
- •4.Is critically ill, and in the judgment of the investigator, unlikely to survive more than 4 months
- •5.Is known to be pregnant or breast-feeding
- •6.Is unable or unwilling to comply with the treatment, assessment, or follow-up schedule
- •7.Is unable to take oral medication
- •8.Has AST or ALT more than 5 times the upper limit of normal for Stage 1, and AST or ALT more than 3 times the upper limit of normal for Stage 2
- •9.Has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe
- •10.Is taking any medications contraindicated with the medicines in any trial regimen
- •11.Has a known allergy to any fluoroquinolone antibiotic
- •12.Is currently taking part in another trial of a medicinal product
- •13.Has a QT or QTcF interval at screening or immediately prior to randomisation of more than or equal to 500 ms for Stage 1, and more than or equal to 450 ms for Stage 2.
- •14.Has experienced one or more of the following risk factors for QT prolongation:
- •Ã¢â?¬Â¢A confirmed prolongation of the QT or QTcF more than or equal to 450 ms in the screening ECG (retesting to reassess eligibility will be allowed once using an unscheduled visit during the screening phase)
- •Ã¢â?¬Â¢Pathological Q-waves (defined as Q-wave more than 40 ms or depth more than 0.4-0.5 mV)
- •Ã¢â?¬Â¢Evidence of ventricular pre-excitation (e.g., Wolff Parkinson White syndrome)
- •Ã¢â?¬Â¢Electrocardiographic evidence of complete or clinically significant incomplete left bundle branch block or right bundle branch block
- •Ã¢â?¬Â¢Evidence of second or third degree heart block
- •Ã¢â?¬Â¢Intraventricular conduction delay with QRS duration more than 120 ms
- •Ã¢â?¬Â¢Bradycardia as defined by sinus rate less than 50 bpm
- •Ã¢â?¬Â¢Personal or family history of Long QT Syndrome
- •Ã¢â?¬Â¢Personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, with the exception of sinus arrhythmia
- •Ã¢â?¬Â¢Syncope (i.e. cardiac syncope not including syncope due to vasovagal or epileptic causes)
- •Ã¢â?¬Â¢Risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, or hypomagnesemia)
- •15.Has received treatment for MDR-TB in the 12 weeks prior to screening, other than the maximum permitted treatment
- •16.Has a history of cirrhosis and classified as Childââ?¬•s B or C at screening or a bilirubin more than 1.5 times upper limit of normal.
- •17.Has an estimated creatinine clearance (CrCl) less than 30 mL/min based on the Cockcraft-Gault equation
- •18.Is HIV positive and has a CD4 count less than 50 cells/mm3
- •19.Has amylase elevation more than two times above the upper limit of normal
- •20.Has a history of alcohol and/or drug abuse
- •21.Has had previous treatment with bedaquiline
- •22.Has taken rifampicin in the seven days prior to randomisation
- •23.There has been a delay of more than four weeks between the scre
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