All-oral shorter treatment regimens for multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB): evaluating their effectiveness, safety, feasibility, cost-effectiveness and impact on the quality of life of patients in Pakista

Phase 2

• Conditions: Multidrug- and rifampicin-resistant tuberculosis; Infections and Infestations; Tuberculosis

• Registration Number: ISRCTN17334530
• Lead Sponsor: World Health Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-08
• Last Update Posted: 22 February 2021
• Study Completion: 2024-06-21

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

The study population includes TB patients with evidence of resistance to at least rifampicin by rapid molecular drug-susceptibility testing (DST).
1. =15 years of age; is willing and able to give informed consent to be enrolled in the research project and for follow-up (signed or witnessed consent if the patient is illiterate)
2. Has bacteriologically or molecularly confirmed TB with evidence of resistance to at least rifampicin
3. Has no resistance to fluoroquinolones; no known previous exposure (of > 1 month) or intolerance to one or more second-line drugs in the shorter MDR-TB regimen

Exclusion Criteria

1. DST showing infection with a strain resistant to fluoroquinolones (or DST results not available)
2. Previous exposure to or intolerance to second-line anti-TB drugs in the intended shorter MDR-TB regimen for more than 1 month
3. Pulmonary TB that is clinically severe, or advanced (i.e. parenchymal lesions) or disseminated
4. Unable to take oral medication, or to attend or comply with treatment or follow-up schedule
5. Taking medication contraindicated with the medicines in the RR/MDRTB regimen
6. Known insufficient function of heart (QTcF >500 ms), liver (ALT/AST >5x UNL), or kidneys (creatinine >2x UNL or creatinine clearance <50 ml/min)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Treatment effectiveness: the proportion of MDR-TB patients who have a favorable treatment outcome. This is defined as 'cured' or 'treatment completed' without recurrence during 12 months after successful treatment.<br> 2. Treatment safety: the proportion of MDR-TB patients included in the study with serious adverse events occurring during treatment and up to12 months after the end of the treatment.<br>