ISRCTN78372190已完成3 期
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
International Union Against Tuberculosis and Lung Disease (IUATLD, Inc.) (USA)0 个研究点目标入组 424 人开始时间: 2010年10月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 424
研究概览
简要总结
2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/25199531 protocol 2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27798041 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30865791 results 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38291393/ (added 31/01/2024) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38462751/ (added 11/03/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 25/01/2016:
- •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 Acid Fast Bacilli (AFB) sputum smear result at screening (at least scanty), unless they are HIV positive in which case a positive GeneXpert result within 4 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 4 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 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 use 2 methods of contraception; men who have not had a vasectomy must agree to use condoms
- •Previous inclusion criteria:
- •1. Willing and able to give informed consent for treatment and follow-up (signed or witnessed consent if the patient is illiterate)
- •2. Aged 15 years or older, either sex
- •3. Has smear-positive pulmonary tuberculosis with initial laboratory result of resistance to rifampicin by line probe assay or other DST
- •4. Is willing to have an HIV test and if positive is willing to be treated with ART in accordance with national policies
- •5. Agrees to use effective barrier contraception or an intrauterine contraceptive device during treatment phase if a pre-menopausal woman
- •6. Has an identifiable address and expects to remain in the area for the duration of the study
- •7. Is willing to adhere to the follow-up schedule and to study procedures
排除标准
- •Current exclusion criteria as of 25/01/2016:
- •1. Is infected with a strain of M. tuberculosis resistant to a second-line injectables by line probe assay
- •2. Is infected with a strain of M. tuberculosis resistant to a fluoroquinolone by line probe assay
- •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 aspartate aminotransferase (AST) or alanine aminotransferase (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 = 450 ms for stage 1, and = 500 ms for stage 2
- •Previous exclusion criteria from 28/09/2011 to 25/01/2016:
- •1. Is infected with a strain of M. tuberculosis resistant to a second-line injectable drug by line probe assay
- •2. Is infected with a strain of M. tuberculosis resistant to a fluoroquinolone by line probe assay
- •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 breastfeeding
- •6. Is unable to attend or comply with treatment or follow-up schedule
- •7. Is unable to take oral medication
- •8. Has AST or ALT >5 times the upper limit of normal
- •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 either the trial or control 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 QTc interval =500 msec at screening
- •Original exclusion criteria:
- •1. Resistant to a second-line injectable drug by line probe assay
- •2. Resistant to a fluoroquinolone by line probe assay
- •3. Critically ill, and in the judgment of the investigator, unlikely to survive more than 4 months
- •4. Known to be pregnant or breastfeeding
- •5. Unable to attend or comply with treatment or follow-up schedule
- •6. Unable to take oral medication
- •7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than three times the upper limit of normal
- •8. Any condition (social or medical) which in the opinion of the investigator would make study participation unsafe or complicate data interpretation
- •9. Taking any medications contraindicated with the medicines in the study regimen
- •10. Known allergy to any fluoroquinolone antibiotic
- •11. Currently taking part in another trial of a medicinal product
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