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New treatment option for Multidrug- and Rifampicin-resistant Tuberculosis
Official title BPaL(M) Regimen for the Treatment of MDR/RR-TB
ClinicalTrials.gov ID: NCT05381194
What this study is testing
What is BPaL(M) regimen?
BPaL(M) regimen is an investigational medicine, being studied as a potential treatment for multidrug- and rifampicin-resistant tuberculosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- At least 19 years old at enrolment
- Bodyweight over 35Kg
- If rifampicin resistance is confirmed through molecular or phenotypic drug susceptibility testing conducted on sputum or bronchoscopy specimens...
- Chest radiological findings consistent with pulmonary tuberculosis
You likely can't join if
- Uncontrolled DM
- Extrapulmonary TB that would require treatment longer than would be usual for pulmonary TB
- Less than 30 Karnofsky score at enrolment
- BMI less than 17
- Known severe allergy to any of the BPaLM regimen drugs
- Medical history of Glucose-galactose malabsorption, galactose intolerance, and Lapp lactase deficiency
See the full eligibility criteria
- At least 19 years old at enrolment
- Bodyweight over 35Kg
- If rifampicin resistance is confirmed through molecular or phenotypic drug susceptibility testing conducted on sputum or bronchoscopy specimens within 3 months of screening
- Chest radiological findings consistent with pulmonary tuberculosis
- Uncontrolled DM
- Extrapulmonary TB that would require treatment longer than would be usual for pulmonary TB
- Less than 30 Karnofsky score at enrolment
- BMI less than 17
- Known severe allergy to any of the BPaLM regimen drugs
- Medical history of Glucose-galactose malabsorption, galactose intolerance, and Lapp lactase deficiency
- HIV-positive
- The QTcF interval exceeds 450 msec on the electrocardiogram at baseline
- Patients who are at risk of Torsade de Pointes due to underlying heart diseases such as heart failure or arrhythmia
- For women of childbearing potential if the pregnancy test is positive, women who are breastfeeding or planning to become pregnant within 6 months of discontinuation/termination of treatment during the study, or who do...
- Men who plan to become pregnant during the study period or within 6 months of discontinuation/termination of treatment, or who do not wish to use double contraception or abstinence during this period.
- Patients who have Grade 3 or 4 or higher peripheral neuritis, or Grade 1 or 2 with a high probability of progression to peripheral neuritis,
- Current use of monoamine oxidase Inhibitor or used 2 weeks before treatment
- Use of serotonergic antidepressant within 3 days of treatment
- Any contraindication that may affect QTc interval (amiodarone, chloroquine, chlorpromazine, clarithromycin, haloperidol, etc.)
- Any contraindication that may cause myelosuppression
- Taking drugs that affect the cytochrome P450 enzyme within 30 days (quinidine, tyramine, ketoconazole, fluconazole, testosterone, quinine, gestodene, metyrapone, phenelzine, doxorubicin, troleandomycin, cyclobenzaprine...
- Previously treated with Bedaquiline or Linezolid for more than 4 weeks
- Abnormal value of a blood test at baseline:
- Hypokalemia, Hemoglobin \< 8.0 g/dL, Platelet \< 75,000/mm3, ANC \< 1000/mm3
- AST or ALT \> 3 X ULN, Total bilirubin \>2.0 X ULN, Albumin \< 3.2 mg/dL
- Serum creatinine \> 2 X ULN, Serum calcium \< LLN, Serum magnesium \< LLN
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Songpa-gu, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Songpa-gu, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.