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Multidrug- and Rifampicin-resistant TuberculosisPhase 4NCT05381194

BPaL(M) Regimen for the Treatment of MDR/RR-TB

A Phase 4 study testing BPaL(M) regimen in people with Multidrug- and Rifampicin-resistant Tuberculosis, run by Asan Medical Center at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
BPaL(M) regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSouth Korea
Study dates
13 Dec 2022to Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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 not want contraception (i.e., oral and subcutaneous hormonal contraceptives, condoms, diaphragms, intrauterine device, or use of appropriate contraceptive methods including abstinence)
  • Note: Double contraception (e.g., when a male uses a barrier contraceptive method such as a condom, a female partner uses a hormonal contraceptive or an additional contraceptive method such as an intrauterine device) is required while taking the study drug and up to 6 months after stopping/terminating the study drug. In particular, taking the study drug may affect the efficacy of hormonal contraceptives, and even if you are using only barrier contraception at the same time with your partner, you cannot be sure of preventing pregnancy, so it is necessary to maintain double contraception.
  • 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, erythromycin, cocaine, furafylline, cimetidine, dextromethorphan, etc.)
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tae Sun Shim, MD, PhD contact

+82-2-3010-3892

shimts@amc.seoul.kr

South Korea1 site, 1 recruiting

  • Asan Medical Center

    Seoul, Songpa-gu, 05505

    Tae Sun Shim, MD, PhD, +82-2-3010-3892, shimts@amc.seoul.kr

    Recruiting

Other trials in South Korea

About this study

Official title: The 6-month BPaL(M) Regimen for the Treatment of Patients With MDR/RR-TB: Multicenter, Single-arm, Operational Research, Clinical Trial

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.

Read the detailed description

The BPaL (Bedaquiline, Pretomanid, Linezolid) regimen has been proven effective for the treatment of Fluoroquinolone-resistant MDR-TB through studies such as the NixTB and ZeNix trials. In addition, the BPaLM regimen has been demonstrated to have excellent efficacy in RR-TB patients through the TB-PRACTECAL study. This study aims to analyze the efficacy of the BPaL(M) regimen in Korean MDR/RR-TB patients.

Being tested
BPaL(M) regimen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BPaL(M) regimenDrug

    Patients diagnosed with MDR/RR-TB are initially assigned to the BPaLM regimen as a single-arm for treatment initiation. Afterward, if MDR/RR-TB is confirmed to be fluoroquinolone-resistant by molecular or phenotypic DST, the treatment is switched to the BPaL regimen (for 24 weeks). On the other hand, if MDR/RR-TB is confirmed to be fluoroquinolone-susceptible, treatment for MDR/RR-TB is maintained with the BPaLM regimen (for 26 weeks).

    The dosage of each medication is as follows:

    • Bedaquiline 400mg/day for the 2 weeks, 200mg/TIW afterward
    • Pretomanid 200mg/day
    • Linezolid 600mg/day for the 9weeks, 300mg/day afterward
    • Moxifloxacin 400mg/day
Study groups in NCT05381194
Study groupRoleWhat they receive
single arm (investigational arm)ExperimentalBPaLM
Receives: Drug: BPaL(M) regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A microbiological failure or clinical failure or relapse

    A microbiological failure or clinical failure or relapse during the treatment period and the 12-month follow-up period after end of treatment

    Measured: until 12 months after the end of treatment

Secondary outcomes (4)

  1. Time to sputum culture conversion during the treatment period

    Analyze the time to liquid and solid culture conversion and estimate the median value using the Kaplan-Meier Method

    Measured: 26 weeks or 24 weeks

  2. Proportion of culture-negative patients at specific times (weeks 4, 8, 12, 16, and 24 or 26)

    Frequency analysis of liquid and solid culture conversion at a specific time point

    Measured: 26 weeks or 24 weeks

  3. Prescribed dose of Linezolid

    Analyze the actual dose of linezolid prescribed

    Measured: 26 weeks or 24 weeks

  4. All-cause mortality

    Analyze the frequency and fraction of deaths and estimate the median using the Kaplan-Meier Method

    Measured: 26 weeks or 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2022
  2. Study start13 Dec 2022
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05381194
Sponsor's protocol ID
BPaL(M)
Status last verified
Mar 2024
First submitted
8 May 2022
Last updated
15 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing BPaL(M) regimen in people with Multidrug- and Rifampicin-resistant Tuberculosis, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tae Sun Shim, MD, PhD (+82-2-3010-3892, shimts@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A microbiological failure or clinical failure or relapse (time frame: until 12 months after the end of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05381194.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.

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