Actively Recruiting
BPaL(M) Regimen for the Treatment of MDR/RR-TB
Led by Asan Medical Center · Updated on 2024-03-15
80
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
Sponsors
A
Asan Medical Center
Lead Sponsor
P
Pusan National University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The objective of this study is to analyze the efficacy of a new regimen using Bedaquiline, Pretomanid, Linezolid, and Moxifloxacin for 24 weeks or Bedaquiline, Pretomanid, Linezolid for 26 weeks for the treatment of MDR/RR-TB through the clinical trial.
CONDITIONS
Official Title
BPaL(M) Regimen for the Treatment of MDR/RR-TB
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 19 years old at enrolment
- Bodyweight over 35 Kg
- Confirmed rifampicin resistance through molecular or phenotypic drug susceptibility testing on sputum or bronchoscopy specimens within 3 months of screening
- Chest X-ray findings consistent with pulmonary tuberculosis
You will not qualify if you...
- Uncontrolled diabetes mellitus
- Extrapulmonary tuberculosis requiring longer treatment than usual for pulmonary TB
- Karnofsky score less than 30 at enrolment
- Body mass index less than 17
- Known severe allergy to any drugs in the BPaLM regimen
- Medical history of glucose-galactose malabsorption, galactose intolerance, or Lapp lactase deficiency
- HIV-positive status
- QTcF interval over 450 msec on baseline electrocardiogram
- Risk of Torsade de Pointes due to heart disease such as heart failure or arrhythmia
- Women who are pregnant, breastfeeding, planning pregnancy within 6 months after treatment, or unwilling to use double contraception
- Men planning pregnancy or unwilling to use double contraception or abstinence during the study and 6 months post-treatment
- Peripheral neuritis Grade 3 or 4, or Grade 1 or 2 with high risk of progression
- Current or recent (within 2 weeks) use of monoamine oxidase inhibitors
- Use of serotonergic antidepressants within 3 days of treatment
- Contraindications affecting QTc interval (e.g., amiodarone, chloroquine, haloperidol)
- Contraindications causing myelosuppression
- Use of drugs affecting cytochrome P450 enzyme within 30 days
- Previous treatment with Bedaquiline or Linezolid for more than 4 weeks
- Abnormal blood test values including hypokalemia, low hemoglobin, low platelets, low neutrophils, elevated liver enzymes, low albumin, elevated creatinine, low calcium, or low magnesium
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, Songpa-gu, South Korea, 05505
Actively Recruiting
Research Team
T
Tae Sun Shim, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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