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Pretomanid is being used in an antimicrobial combination regimen(s) to treat patients with pulmonary tuberculosis (TB). The primary purpose of the Male Reproductive Safety - "BPaMZ/SEM"- clinical study is to evaluate the potential effect of pretomanid on human testicular function whilst being used in a 26 weeks antimicrobial combination regimen consisting of bedaquiline (B) plus pretomanid (Pa) plus moxifloxacin (M) and pyrazinamide (Z) (BPaMZ).
The primary objective of this study is to assess the male reproductive safety of pretomanid in the regimen (BPaMZ) of bedaquiline 200mg (200mg daily for 8 weeks then 100 mg daily for 18 weeks), together with pretomanid 200 mg (1x daily) + moxifloxacin 400 mg (1x daily) + pyrazinamide 1500 mg (1 x daily) for 26 weeks in participants with drug-resistant pulmonary tuberculosis (DR-TB).
The secondary objective of the study is to evaluate the tuberculosis (TB) treatment efficacy, safety and tolerability after 26 weeks of active treatment for TB and follow up until 52 weeks after end of the above-described treatment regimen in participants with DR-TB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Participants | Experimental | Participants will receive bedaquiline 200 mg once daily for 8 weeks then 100 mg once daily for 18 weeks together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg once daily (BPaMZ) for 26 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pretomanid | Drug | pretomanid 200 mg (once daily) for 26 weeks (with meal) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change Form Baseline Total Sperm Count | Change from baseline in total sperm number at 26 weeks of therapy. Total sperm count is calculated by multiplying the sperm cell concentration by the ejaculate volume. | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Sperm Count at 12 Weeks | Change from baseline in total sperm number at 12 weeks of therapy. Total sperm count is calculated by multiplying the sperm cell concentration by the ejaculate volume. | Baseline to Week 12 |
| Change From Baseline Total Sperm Count at 44 Weeks |
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Inclusion Criteria:
Understands study procedures and voluntarily provides written informed consent prior to the start of any study-specific procedures.
Male gender 18 years or over
Body weight (in light clothing and no shoes) ≥ 45kg.
A positive molecular test for tuberculosis in sputum either at screening or within one month prior to enrolment.
Disease Characteristics:
A chest x-ray, within 26 weeks prior to or at the screening visit, which in the opinion of the Investigator is compatible with pulmonary TB
Exclusion criteria:
Resistant to fluoroquinolones by rapid molecular test
History of male infertility or vasectomy
Unable to produce semen sample
Evidence at screening of azoospermia
Known erectile dysfunction that would prevent ejaculation.
Historical or active disease process of the male reproductive tract that would compromise sperm production. e.g. tuberculous epididymitis.
History of any illness that, in the opinion of the Investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
For HIV infected participants any of the following:
Participants with newly diagnosed tuberculosis and HIV that require initiation of appropriate HIV therapy before participants has received at least 2 weeks of an antituberculosis regimen.
Received pretomanid and/or delamanid to treat TB
Known chronic hepatitis B or C
For HIV infected participants:
1. Stavudine 2. Zidovudine 3. Didanosine 4. Triple NRTI regimen is not considered optimal for HIV treatment (poor efficacy)
13. Participants with the following toxicities at screening as defined by the enhanced Division of Microbiology and Infectious Disease (DMID) adult toxicity table (Draft November 2007) where applicable:
Platelets <75,000/mm3
Creatinine >1.5 times upper limit of normal (ULN)
eGFR ≤ 60 mL/min
Haemoglobin <8.0 g/dL
Serum potassium less than the lower limit of normal for the laboratory. This may be repeated once
AST:
ALT:
ALP:
Total bilirubin:
Direct bilirubin:
• greater than 1x ULN to be excluded
Positive hepatitis B surface Ag, or hepatitis C antibody
males 18 years of age or older
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Lombardi, MD | Global Alliance for TB Drug Development | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center for Tuberculosis and Lung Diseases | Tbilisi | Georgia | ||||
| CHRU, Sizwe Tropical Diseases Hospital |
No pre-assignment events occurred.
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| ID | Title | Description |
|---|---|---|
| FG000 | BPaMZ | Participants will receive bedaquiline 200 mg once daily for 8 weeks then 100 mg once daily for 18 weeks together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg once daily (BPaMZ) for 26 weeks. Pretomanid: pretomanid 200 mg (once daily) for 26 weeks (with meal) Bedaquiline: bedaquiline 200 mg (once daily) for 8 weeks (with meal), then bedaquiline 100mg (once daily) for 18 weeks (with meal) moxifloxacin: moxifloxacin 400 mg (once daily) for 26 weeks (with meal) pyrazinamide: pyrazinamide 1500 mg (once daily) for 26 weeks (with meal) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 7, 2022 | Jul 12, 2024 |
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Phase 2 single arm multi-center, open-label clinical trial in DR-TB participants. Participants will receive bedaquiline 200 mg once daily for 8 weeks then 100 mg once daily for 18 weeks together with pretomanid 200 mg
+ moxifloxacin 400 mg + pyrazinamide 1500 mg once daily (BPaMZ) for 26 weeks.
Participants will be followed for 52 weeks after end of treatment
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| Bedaquiline | Drug | bedaquiline 200 mg (once daily) for 8 weeks (with meal), then bedaquiline 100mg (once daily) for 18 weeks (with meal) |
|
|
| moxifloxacin | Drug | moxifloxacin 400 mg (once daily) for 26 weeks (with meal) |
|
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| pyrazinamide | Drug | pyrazinamide 1500 mg (once daily) for 26 weeks (with meal) |
|
|
Change from baseline in total sperm number at 44 weeks (18 months post treatment completion). Total sperm count is calculated by multiplying the sperm cell concentration by the ejaculate volume. |
| Baseline through 44 weeks |
| Luteinizing Hormone (LH) | (LH) at baseline, 26, 44, and 78 weeks. | Baseline to Week 78 |
| FSH | FSH at baseline, weeks 26, 44 and 78 | Baseline to week 78 |
| Testosterone | testosterone level at baseline, 26, 44 and 78 weeks. | Baseline to 78 weeks |
| Inhibin B | inhibin B at baseline, weeks 26, 44 and 78 | Baseline to 78 weeks |
| Johannesburg |
| South Africa |
| Isango Lethemba TB Research Unit Empilweni TB Hospital | Port Elizabeth | South Africa |
| The Aurum Institute: Rustenburg Clinical Research Centre | Rustenburg | South Africa |
| COMPLETED |
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| NOT COMPLETED |
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| Follow-up |
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Total Enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | BPaMZ | Participants will receive bedaquiline 200 mg once daily for 8 weeks then 100 mg once daily for 18 weeks together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg once daily (BPaMZ) for 26 weeks. Pretomanid: pretomanid 200 mg (once daily) for 26 weeks (with meal) Bedaquiline: bedaquiline 200 mg (once daily) for 8 weeks (with meal), then bedaquiline 100mg (once daily) for 18 weeks (with meal) moxifloxacin: moxifloxacin 400 mg (once daily) for 26 weeks (with meal) pyrazinamide: pyrazinamide 1500 mg (once daily) for 26 weeks (with meal) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||||
| Weight | Least Squares Mean | Standard Deviation | kg |
| |||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | Kg/m^2 |
| |||||||||||||||||
| HIV Status | Count of Participants | Participants |
| ||||||||||||||||||
| Smoking | Count of Participants | Participants |
| ||||||||||||||||||
| Alcohol use | Count of Participants | Participants |
| ||||||||||||||||||
| Previous Tuberculosis (TB) diagnoses | participant may have had more than one occurrences of previous TB diagnosis and could select more than one category. | Count of Participants | Participants |
| |||||||||||||||||
| Screening smear microscopy for Acid Fast Bacilli (AFB) | Detected acid-fast bacilli (AFB) by microscopic examination of clinical sputum specimens and cultures collected from participants. A quantitative grading system (WHO/IUATLD scaling system) was used to report the number of AFB observed in stained smears from concentrated sputum specimens, ranging from none seen to a 3+, depending on the amount of bacilli counted on microscopic examination. | Count of Participants | Participants |
| |||||||||||||||||
| Time to positivity at baseline | The Time to Positivity (TTP) analysis is based on the number of participants who had a positive MGIT at baseline. One MGIT result had not been reported at the time the primary results were reported. N=21 in subsequent reports. | Only for those positive (MGIT) at baseline (between Day 1 and Week 4) | Mean | Standard Deviation | Days |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change Form Baseline Total Sperm Count | Change from baseline in total sperm number at 26 weeks of therapy. Total sperm count is calculated by multiplying the sperm cell concentration by the ejaculate volume. | Excludes participants not meeting definition of having received adequate treatment (80% of allocated doses) or with major protocol deviations including participants who did not satisfy entry criteria but were entered anyway; participants who developed withdrawal criteria during the study but were not withdrawn; and participants who received the wrong treatment or incorrect dose.. | Posted | Mean | Standard Deviation | 10^6 sperm cells/ejaculate | Week 26 |
|
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| |||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Sperm Count at 12 Weeks | Change from baseline in total sperm number at 12 weeks of therapy. Total sperm count is calculated by multiplying the sperm cell concentration by the ejaculate volume. | Excludes participants not meeting definition of having received adequate treatment (80% of allocated doses)or with major protocol deviations including participants who did not satisfy entry criteria but were entered anyway; participants who developed withdrawal criteria during the study but were not withdrawn; and participants who received the wrong treatment or incorrect dose. | Posted | Mean | Standard Deviation | 10^6 sperm cells/ejaculate | Baseline to Week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline Total Sperm Count at 44 Weeks | Change from baseline in total sperm number at 44 weeks (18 months post treatment completion). Total sperm count is calculated by multiplying the sperm cell concentration by the ejaculate volume. | All enrolled participants who completed the 44-week visit. | Posted | Mean | Standard Deviation | 10^6 sperm cells/ejaculate | Baseline through 44 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Luteinizing Hormone (LH) | (LH) at baseline, 26, 44, and 78 weeks. | Total assessable. (Excludes participants who were lost to follow-up or with missing data) | Posted | Median | Inter-Quartile Range | IU/mL | Baseline to Week 78 |
| |||||||||||||||||||||||||||
| Secondary | FSH | FSH at baseline, weeks 26, 44 and 78 | Total assessable. (Excludes participants who were lost to follow-up or with missing data) | Posted | Median | Inter-Quartile Range | IU/mL | Baseline to week 78 |
| |||||||||||||||||||||||||||
| Secondary | Testosterone | testosterone level at baseline, 26, 44 and 78 weeks. | Total assessable. (Excludes participants who were lost to follow-up or with missing data) | Posted | Median | Inter-Quartile Range | ng/dL | Baseline to 78 weeks |
| |||||||||||||||||||||||||||
| Secondary | Inhibin B | inhibin B at baseline, weeks 26, 44 and 78 | Total assessable. (Excludes participants who were lost to follow-up or with missing data) | Posted | Median | Inter-Quartile Range | pg/mL | Baseline to 78 weeks |
|
All adverse events (including Serious adverse events) listed in result's are treatment emergent; defined in this trial AEs which started or worsened on or after the first administration of BPaMZ up to and including last date scheduled study drug (up to 26 weeks) was administered plus 2 weeks following last treatment dose. .
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BPaMZ | Participants will receive bedaquiline 200 mg once daily for 8 weeks then 100 mg once daily for 18 weeks together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg once daily (BPaMZ) for 26 weeks. Pretomanid: pretomanid 200 mg (once daily) for 26 weeks (with meal) Bedaquiline: bedaquiline 200 mg (once daily) for 8 weeks (with meal), then bedaquiline 100mg (once daily) for 18 weeks (with meal) moxifloxacin: moxifloxacin 400 mg (once daily) for 26 weeks (with meal) pyrazinamide: pyrazinamide 1500 mg (once daily) for 26 weeks (with meal) | 1 | 26 | 2 | 26 | 21 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| infective exacerbation of bronchiectasis | Infections and infestations | MedDRA v 26.0 | Non-systematic Assessment |
| |
| hepatic enzyme increased | Investigations | MedDRA v 26.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders | MedDRA v 26.0 | Non-systematic Assessment |
| |
| diarrhoea | Gastrointestinal disorders | MedDRA v 26.0 | Non-systematic Assessment |
| |
| gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v 26.0 | Non-systematic Assessment |
| |
| haemorrhoids | Gastrointestinal disorders | MedDRA v 26.0 | Non-systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA v 26.0 | Non-systematic Assessment |
| |
| hypertransaminasaemia | Hepatobiliary disorders | MedDRA v 26.0 | Non-systematic Assessment |
| |
| conjunctivitis | Infections and infestations | MedDRA v 26.0 | Non-systematic Assessment |
| |
| lower respiratory infection | Infections and infestations | MedDRA v 26.0 | Non-systematic Assessment |
| |
| pneumonia | Infections and infestations | MedDRA v 26.0 | Non-systematic Assessment |
| |
| upper respiratory tract infection | Infections and infestations | MedDRA v 26.0 | Non-systematic Assessment |
| |
| aspartate aminotransferase increased | Investigations | MedDRA v 26.0 | Non-systematic Assessment |
| |
| blood potassium decreased | Investigations | MedDRA v 26.0 | Non-systematic Assessment |
| |
| blood uric acid increased | Investigations | MedDRA v 26.0 | Non-systematic Assessment |
| |
| gamma-glutamyltransferase increased | Investigations | MedDRA v 26.0 | Non-systematic Assessment |
| |
| hepatic enzyme increased | Investigations | MedDRA v 26.0 | Non-systematic Assessment |
| |
| decreased appetite | Metabolism and nutrition disorders | MedDRA v 26.0 | Non-systematic Assessment |
| |
| hyperuricaemia | Metabolism and nutrition disorders | MedDRA v 26.0 | Non-systematic Assessment |
| |
| hyponatraemia | Metabolism and nutrition disorders | MedDRA v 26.0 | Non-systematic Assessment |
| |
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v 26.0 | Non-systematic Assessment |
| |
| myalgia | Musculoskeletal and connective tissue disorders | MedDRA v 26.0 | Non-systematic Assessment |
| |
| dizziness | Nervous system disorders | MedDRA v 26.0 | Non-systematic Assessment |
| |
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA v 26.0 | Non-systematic Assessment |
| |
| haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v 26.0 | Non-systematic Assessment |
| |
| pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v 26.0 | Non-systematic Assessment |
| |
| pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA v 26.0 | Non-systematic Assessment |
| |
| dry skin | Skin and subcutaneous tissue disorders | MedDRA v 26.0 | Non-systematic Assessment |
| |
| pruritus | Skin and subcutaneous tissue disorders | MedDRA v 26.0 | Non-systematic Assessment |
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Institution and Principal Investigator shall not publish, present or use the Study Data for its own instruction, research or publication without the prior express written consent of Sponsor. Because the Study is funded, in whole or in part, by the Bill and Melinda Gates Foundation (the "Foundation"), all peer-reviewed published research relating to the Study must comply with the Foundation's Open Access Policy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antonio Lombardi | TB Alliance | 917-601-0024 | Antonio.Lombardi-Consultant@tballiance.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 19, 2023 | Jul 12, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| D018088 | Tuberculosis, Multidrug-Resistant |
| D014376 | Tuberculosis |
| D054908 | Extensively Drug-Resistant Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C410767 | pretomanid |
| C493870 | bedaquiline |
| D000077266 | Moxifloxacin |
| D011718 | Pyrazinamide |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Former |
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| Former |
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| INH Mono-resistant TB |
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| RIF mono-resistant TB |
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| MDR-TB |
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| Scanty Positive |
|
| 1+ |
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| 2+ |
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| 3+ |
|
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| OG002 | BPaMZ 44 Weeks | Participants will receive bedaquiline 200 mg once daily for 8 weeks then 100 mg once daily for 18 weeks together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg once daily (BPaMZ) for 26 weeks. Pretomanid: pretomanid 200 mg (once daily) for 26 weeks (with meal) Bedaquiline: bedaquiline 200 mg (once daily) for 8 weeks (with meal), then bedaquiline 100mg (once daily) for 18 weeks (with meal) moxifloxacin: moxifloxacin 400 mg (once daily) for 26 weeks (with meal) pyrazinamide: pyrazinamide 1500 mg (once daily) for 26 weeks (with meal) |
| OG003 | BPaMZ 78 Weeks | Participants will receive bedaquiline 200 mg once daily for 8 weeks then 100 mg once daily for 18 weeks together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg once daily (BPaMZ) for 26 weeks. Pretomanid: pretomanid 200 mg (once daily) for 26 weeks (with meal) Bedaquiline: bedaquiline 200 mg (once daily) for 8 weeks (with meal), then bedaquiline 100mg (once daily) for 18 weeks (with meal) moxifloxacin: moxifloxacin 400 mg (once daily) for 26 weeks (with meal) pyrazinamide: pyrazinamide 1500 mg (once daily) for 26 weeks (with meal) |
|
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| OG002 |
| BPaMZ 44 Weeks |
Participants will receive bedaquiline 200 mg once daily for 8 weeks then 100 mg once daily for 18 weeks together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg once daily (BPaMZ) for 26 weeks. Pretomanid: pretomanid 200 mg (once daily) for 26 weeks (with meal) Bedaquiline: bedaquiline 200 mg (once daily) for 8 weeks (with meal), then bedaquiline 100mg (once daily) for 18 weeks (with meal) moxifloxacin: moxifloxacin 400 mg (once daily) for 26 weeks (with meal) pyrazinamide: pyrazinamide 1500 mg (once daily) for 26 weeks (with meal) |
| OG003 | BPaMZ 78 Weeks | Participants will receive bedaquiline 200 mg once daily for 8 weeks then 100 mg once daily for 18 weeks together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg once daily (BPaMZ) for 26 weeks. Pretomanid: pretomanid 200 mg (once daily) for 26 weeks (with meal) Bedaquiline: bedaquiline 200 mg (once daily) for 8 weeks (with meal), then bedaquiline 100mg (once daily) for 18 weeks (with meal) moxifloxacin: moxifloxacin 400 mg (once daily) for 26 weeks (with meal) pyrazinamide: pyrazinamide 1500 mg (once daily) for 26 weeks (with meal) |
|
|
| OG002 | BPaMZ 44 Weeks | Participants will receive bedaquiline 200 mg once daily for 8 weeks then 100 mg once daily for 18 weeks together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg once daily (BPaMZ) for 26 weeks. Pretomanid: pretomanid 200 mg (once daily) for 26 weeks (with meal) Bedaquiline: bedaquiline 200 mg (once daily) for 8 weeks (with meal), then bedaquiline 100mg (once daily) for 18 weeks (with meal) moxifloxacin: moxifloxacin 400 mg (once daily) for 26 weeks (with meal) pyrazinamide: pyrazinamide 1500 mg (once daily) for 26 weeks (with meal) |
| OG003 | BPaMZ 78 Weeks | Participants will receive bedaquiline 200 mg once daily for 8 weeks then 100 mg once daily for 18 weeks together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg once daily (BPaMZ) for 26 weeks. Pretomanid: pretomanid 200 mg (once daily) for 26 weeks (with meal) Bedaquiline: bedaquiline 200 mg (once daily) for 8 weeks (with meal), then bedaquiline 100mg (once daily) for 18 weeks (with meal) moxifloxacin: moxifloxacin 400 mg (once daily) for 26 weeks (with meal) pyrazinamide: pyrazinamide 1500 mg (once daily) for 26 weeks (with meal) |
|
|
| OG002 | BPaMZ 44 Weeks | Participants will receive bedaquiline 200 mg once daily for 8 weeks then 100 mg once daily for 18 weeks together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg once daily (BPaMZ) for 26 weeks. Pretomanid: pretomanid 200 mg (once daily) for 26 weeks (with meal) Bedaquiline: bedaquiline 200 mg (once daily) for 8 weeks (with meal), then bedaquiline 100mg (once daily) for 18 weeks (with meal) moxifloxacin: moxifloxacin 400 mg (once daily) for 26 weeks (with meal) pyrazinamide: pyrazinamide 1500 mg (once daily) for 26 weeks (with meal) |
| OG003 | BPaMZ 78 Weeks | Participants will receive bedaquiline 200 mg once daily for 8 weeks then 100 mg once daily for 18 weeks together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg once daily (BPaMZ) for 26 weeks. Pretomanid: pretomanid 200 mg (once daily) for 26 weeks (with meal) Bedaquiline: bedaquiline 200 mg (once daily) for 8 weeks (with meal), then bedaquiline 100mg (once daily) for 18 weeks (with meal) moxifloxacin: moxifloxacin 400 mg (once daily) for 26 weeks (with meal) pyrazinamide: pyrazinamide 1500 mg (once daily) for 26 weeks (with meal) |
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