Phase 2 Tuberculosis Trial, Recruiting NCT07517445 Sponsor: Gates Medical Research Institute Condition: Tuberculosis
Back to Tuberculosis

Phase 2 Tuberculosis Trial, Recruiting

NCT07517445
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 65 years old at the time of signing the consent form
  • You weigh between 40 and 100 kg at the time of your screening appointment
  • You are willing and able to sign a written consent form to participate
  • You have been newly diagnosed with tuberculosis (TB) in the lungs, and your TB responds to the standard antibiotics rifampicin and isoniazid
  • Your TB diagnosis has been confirmed through a sputum (phlegm) test showing a certain level of TB bacteria, as well as a molecular (genetic) test confirming it is TB
  • Your chest X-ray shows signs consistent with TB, as assessed by the trial doctor
  • You are able to cough up sputum (phlegm) on your own without assistance
  • You are using an acceptable form of birth control or abstinence as required by the trial (women of childbearing potential must use 2 approved methods; men must use contraception or abstinence for 90 days after their last dose)

Who may not be able to join:

  • You have had TB in the past 3 years, more than one previous episode of TB, or have taken TB treatment in the last 60 days
  • Your TB has spread outside the lungs (with some exceptions for minor involvement of the lining around the lungs or nearby lymph nodes — confirm with trial site)
  • You have other significant health conditions or substance use issues that could affect your safety or ability to follow the trial requirements (confirm with trial site)
  • You are currently pregnant or breastfeeding
  • You are HIV-positive and are not yet on HIV treatment, have been on HIV treatment for less than 3 months, have a low immune cell count (CD4 below 200), have a detectable HIV viral load above 200 copies/mL, or have a serious HIV-related illness other than lung TB
  • Your blood or urine tests at screening show abnormal results in areas such as liver function, blood counts, hepatitis B or C infection, or blood sugar levels (confirm specific thresholds with trial site)
  • Your heart tracing (ECG) shows a significant abnormality
  • You are taking certain medications that are not allowed in this trial, such as strong drugs that affect how the body processes medications, or certain antidepressants (confirm your full medication list with the trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Gates MRI, Gates Medical Research Institute

Phone: +857-702-2108

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Gates Medical Research Institute
Registry
ClinicalTrials.gov
Start date
17 April 2026
Est. completion
14 June 2027

Where this trial is recruiting

🇿🇦 South Africa

Primary endpoints

Bactericidal Activity; Safety: SAEs; Safety: TEAEs; Safety: AESIs; Safety: TEAEs leading to treatment discontinuation; Safety: TEAEs leading to NAM dose reduction

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov