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Tests treatment safety and results for Drug Susceptible Pulmonary Tuberculosis
Official title Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis
ClinicalTrials.gov ID: NCT07517445
What this study is testing
What is Bedaquiline, pretomanid, linezolid?
Bedaquiline, pretomanid, linezolid is an investigational medicine, given as an once-daily, being studied as a potential treatment for drug susceptible pulmonary 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 purpose of this study is to determine if nicotinamide in combination with bedaquiline, pretomanid, and linezolid, is safe and effective in treating drug-susceptible pulmonary tuberculosis.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age 18-65 years at consent
- Body weight 40-100 kg at screening
- Written informed consent obtained
- Newly diagnosed pulmonary TB, rifampicin- and isoniazid-sensitive
- ≥1+ AFB smear OR positive Xpert semi-quantitative result
You likely can't join if
- Prior TB within 3 years, \>1 prior episode, or anti-TB treatment within 60 days
- Extrapulmonary TB (except non-significant pleural/lymph node disease)
- Clinically significant comorbidities or substance abuse impacting safety/compliance
- Pregnant or breastfeeding
- HIV-positive AND any of the following:
- Not on ART or on ART \<3 months
See the full eligibility criteria
- Age 18-65 years at consent
- Body weight 40-100 kg at screening
- Written informed consent obtained
- Newly diagnosed pulmonary TB, rifampicin- and isoniazid-sensitive
- ≥1+ AFB smear OR positive Xpert semi-quantitative result
- Molecular confirmation of M. tuberculosis
- Chest X-ray consistent with TB (Investigator assessment)
- Able to spontaneously produce sputum
- Contraception requirements met
- Females Of Child Bearing Potential: 2 approved contraceptive methods or abstinence
- Males: contraception or abstinence through 90 days post-dose
- Prior TB within 3 years, \>1 prior episode, or anti-TB treatment within 60 days
- Extrapulmonary TB (except non-significant pleural/lymph node disease)
- Clinically significant comorbidities or substance abuse impacting safety/compliance
- Pregnant or breastfeeding
- HIV-positive AND any of the following:
- Not on ART or on ART \<3 months
- CD4 \<200 cells/µL
- Viral load \>200 copies/mL
- AIDS-defining illness (other than pulmonary TB)
- Screening lab abnormalities (protocol-defined LFTs, hematology, hepatitis B or C, HbA1c)
- Clinically significant ECG abnormality
- Use of prohibited concomitant medications (e.g., strong CYP3A4 modifiers, certain SSRIs)
The study team makes the final eligibility decision.
Where it's taking place
- Johannesburg, Gauteng, South Africa
- Pretoria, Gauteng, South Africa
- Cape Town, Western Cape, South Africa
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, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Johannesburg, Gauteng, South Africa; Pretoria, Gauteng, South Africa; Cape Town, Western Cape, South Africa. 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.