The evaluation of a standardised treatment regimen of anti-tuberculosis drugs for patients with multi-drug-resistant tuberculosis (MDR-TB)
- Conditions
- Multidrug resistant pulmonary tuberculosis (MDR-TB)Infections and InfestationsTuberculosis
- Registration Number
- ISRCTN78372190
- Lead Sponsor
- International Union Against Tuberculosis and Lung Disease (IUATLD, Inc.) (USA)
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 424
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method