BridgeMD
New treatment option for Drug Susceptible Pulmonary Tuberculosis
Official title Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis
ClinicalTrials.gov ID: NCT07525427
What this study is testing
What is Bedaquiline, pretomanid and TBD09?
Bedaquiline, pretomanid and TBD09 is an investigational medicine, given as an once-weekly, 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 evaluate if TBD09 in combination with other active agents in adults with drug sensitive pulmonary tuberculosis has potential to be safe and effective.
- 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 35-100 kg at screening
- Written informed consent obtained
- Newly diagnosed rifampicin-sensitive pulmonary TB
- Molecular confirmation of M. tuberculosis on Xpert MTB/RIF Ultra
You likely can't join if
- Prior anti-TB treatment for the current TB episode within 60 days
- Prior medication active against Mtb within 3 months
- Evidence of extra-thoracic TB, per investigator judgement
- Prior treatment completion for TB within 3 years
- 2 or more prior episodes of TB
- Clinically significant history of or current medical condition posing safety risk
See the full eligibility criteria
- Age 18-65 years at consent
- Body weight 35-100 kg at screening
- Written informed consent obtained
- Newly diagnosed rifampicin-sensitive pulmonary TB
- Molecular confirmation of M. tuberculosis on Xpert MTB/RIF Ultra
- ≥1+ AFB smear or Xpert Ultra low, medium, or high semi-quantitative result
- Rifampicin sensitivity on molecular test
- Chest X-ray consistent with TB (Investigator assessment)
- Able to spontaneously produce sputum
- Reproductive requirements met
- Women of childbearing potential: 2 approved contraceptive methods or abstinence
- Males: contraception or abstinence through 90 days post-dose
- Prior anti-TB treatment for the current TB episode within 60 days
- Prior medication active against Mtb within 3 months
- Evidence of extra-thoracic TB, per investigator judgement
- Prior treatment completion for TB within 3 years
- 2 or more prior episodes of TB
- Clinically significant history of or current medical condition posing safety risk
- If HIV positive:
- Not on ARVs or taking ARVs for \<3 months prior to screening OR
- CD4+ count \<200cells/uL at screening OR
- HIV viral load \>200 copies /mL at screening OR
- AIDS infection or malignancies
- Meets any of the following laboratory values during screening:
- AST, ALT, or ALP ≥2.5× ULN
- Total bilirubin ≥1.2× ULN
- eGFR \<60 mL/min/1.73 m²
- Hemoglobin \<9.0 g/dL (male) or \<8.5 g/dL (female)
- White blood cell count \<2,000/mm³
- Absolute neutrophil count \<800/mm³
- Platelet count ≤100,000/mm³
- Positive hepatitis B surface antigen
- Positive hepatitis C antibody
- HbA1c ≥8.0%
- Current or recent systemic immunosuppressive therapy, including corticosteroids
- Significant drug or alcohol abuse affecting compliance or safety
- Pregnant or breastfeeding, positive pregnancy test, or planning pregnancy shortly after treatment
The study team makes the final eligibility decision.
Where it's taking place
- Durban, Bluff, South Africa
- George, Central, South Africa
- Johannesburg, Gauteng, South Africa
- Tembisa, Gauteng, South Africa
- Bethelsdorp, Gqeberha, South Africa
- Brits, North West, South Africa
- Pretoria, Soshangue, South Africa
- Cape Town, Western Cape, South Africa
- East London, 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 Durban, Bluff, South Africa; George, Central, South Africa; Johannesburg, Gauteng, South Africa; Tembisa, Gauteng, South Africa; Bethelsdorp, Gqeberha, South Africa; Brits, North West, South Africa and 3 more location(s). 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.