CTRI/2017/09/009693
Active, Not Recruiting
Phase 3
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 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The international Union Against Tuberculosis and lung diseases
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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