Safety and effectiveness of a 6-month all-oral treatment regimen for the treatment of rifampicin-resistant tuberculosis in Vietnam
- Conditions
- Treatment of fluoroquinolones susceptible rifampicin-resistant TB patientsInfections and Infestations
- Registration Number
- ISRCTN18086293
- Lead Sponsor
- Vietnam National Lung Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 400
1. Diagnosed with pulmonary TB by a microbiological test (molecular or phenotypic), and has laboratory-confirmed resistance to at least rifampicin by either molecular or phenotypic drug susceptibility test
2. Fluoroquinolone resistance excluded either on phenotypic or genotypic DST
3. Aged 15 years or above, regardless of HIV status, at the time of enrolment
4. Willing and able to give informed consent to be enrolled in the trial and adhere to the trial procedures and follow-up schedule (signed or witnessed consent if illiterate)
1. Known allergies, hypersensitivity, or intolerance to any of the BPaL-M/Lf component drugs
2. Pregnant or breast-feeding
3. Liver enzymes >3 times the upper limit of normal (AST or ALT)
4. Taking any medications contraindicated with the medicines in the trial
5. QTcF > 450ms
6. Peripheral neuropathy of Grade 3–4
7. Any baseline biochemical laboratory value consistent with Grade 4 toxicity
8. Has DST showing infection with a strain resistant to any of the study regimens’ component drugs (Bdq, Pa, Lzd, Mfx or Lfx) or delamanid (Dlm)
9. Has been previously exposed to any of the BPaL-M/Lf drugs (Bdq, Pa, Lzd, Mfx or Lfx) or Dlm for more than four weeks, unless DST confirms susceptibility to these drugs
10. The clinical DR-TB committee decides that it is not in the best interest of the patient to be enrolled on the BPaL-M/Lfx due to the necessity of an individualized TB treatment regimen
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method QT interval corrected for heart rate using Fridericia's formula (QTcF) prolongation (difference between baseline QTcF interval and highest value during treatment for the QTcF interval) measured using electrocardiogram (ECG) at baseline, 2 weeks after treatment starts and monthly until treatment completes
- Secondary Outcome Measures
Name Time Method