ISRCTN18148631已完成未知
The evaluation of a Standardised Treatment REgimen of Anti-tuberculosis drugs for patients with Multi-drug-resistant tuberculosis (MDR-TB): A multi-centre international parallel group randomised controlled trial
Vital Strategies (Formally International Union Against Tuberculosis and Lung Disease)0 个研究点目标入组 588 人开始时间: 2016年2月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 588
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33371043/ economic evaluation protocol for bedaquiline-containing regimen (added 08/03/2021) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35672833/ Design changes (added 08/06/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36368336/ (added 14/11/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36565704/ Economic evaluation of bedaquiline-containing regimens (added 28/12/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 18/02/2019:
- •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). If the patient is below the age of consent (according to local regulations), the parent/caregiver should be able and willing to give consent, and the patient be informed about the study and asked to give positive assent, if feasible
- •2. Is aged 15 years or older
- •3. Has a positive AFB sputum smear result at screening (at least scanty), or a positive GeneXpert result (with a cycle threshold (Ct) value of 25 or lower) within four weeks prior to screening 4. Has evidence of resistance to rifampicin either by line probe assay (Hain Genotype), 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 (men who have not had a vasectomy must agree to use condoms; 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 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.
- •Previous participant inclusion criteria as of 29/10/2018:
- •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). If the patient is below the age of consent (according to local regulations), the parent/caregiver should be able and willing to give consent, and the patient be informed about the study and asked to give positive assent, if feasible
- •2. Is aged 15 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 (men who have not had a vasectomy must agree to use condoms; 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
排除标准
- •Participant exclusion criteria as of 29/10/2018:
- •1. Is infected with a strain of M. tuberculosis resistant to a second-line injectables by line probe assay (Hain Genotype) from a test performed at screening or from a test performed within the four weeks prior to screening
- •2. Is infected with a strain of M. tuberculosis resistant to a fluoroquinolone by line probeassay (Hain Genotype) from a test performed at screening or from a test performed within the four weeks prior to screening
- •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 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. In the investigator’s opinion the patient is likely to be eligible for treatment with bedaquiline according to local guidelines due a pre-existing medical condition such as hearing loss or renal impairment
- •11. Is taking any medications contraindicated with the medicines in any trial regimen
- •12. Has a known allergy to any fluoroquinolone antibiotic
- •13. Is currently taking part in another trial of a medicinal product
- •14. Has a QT or QTcF interval at screening or immediately prior to randomisation of more than or equal to 450 ms for Stage 2.
- •15. Has experienced one or more of the following risk factors for QT prolongation:
- •15.1. 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)
- •15.2. Pathological Q-waves (defined as Q-wave more than 40 ms or depth more than 0.4-0.5 mV)
- •15.3. Evidence of ventricular pre-excitation (e.g., Wolff Parkinson White syndrome)
- •15.4. Electrocardiographic evidence of complete or clinically significant incomplete left bundle branch block or right bundle branch block
- •15.5. Evidence of second or third degree heart block
- •15.6. Intraventricular conduction delay with QRS duration more than 120 ms
- •15.7. Bradycardia as defined by sinus rate less than 50 bpm
- •15.8. Personal or family history of Long QT Syndrome
- •15.9. Personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, with the exception of sinus arrhythmia
- •15.10. Syncope (i.e. cardiac syncope not including syncope due to vasovagal or epileptic causes)
- •15.11. Risk factors for Torsades de Pointes (e.g., heart failure, hypokalaemia, or hypomagnesemia)
- •16. Has received treatment for MDR-TB in the 12 weeks prior to screening
- •17. Has a history of cirrhosis and classified as Child’s B or C at screening or a bilirubin more than 1.5 times upper limit of normal.
- •18. Has an estimated creatinine clearance (CrCl) less than 30 mL/min based on
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