Phase 2 Tuberculosis Trial, Recruiting NCT07525427 Sponsor: Gates Medical Research Institute Condition: Tuberculosis
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Phase 2 Tuberculosis Trial, Recruiting

NCT07525427
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:

  • People aged 18 to 65 years old at the time of giving consent
  • People weighing between 35 and 100 kg at the screening visit
  • People who have given written consent to take part
  • People newly diagnosed with pulmonary tuberculosis (TB in the lungs) that is sensitive to the antibiotic rifampicin, confirmed by a specific molecular test (Xpert MTB/RIF Ultra)
  • People whose TB diagnosis is supported by a sputum smear test or a qualifying result on the Xpert Ultra test
  • People whose chest X-ray shows findings consistent with TB, as assessed by the trial doctor
  • People who are able to cough up sputum (mucus from the lungs) on their own
  • Women who could become pregnant must be using two approved methods of contraception, or be abstaining from sex
  • Men must be using contraception or abstaining from sex for at least 90 days after their last dose

Who may not be able to join:

  • People who have received any anti-TB treatment for their current TB episode in the past 60 days
  • People who have taken any medication active against TB within the past 3 months
  • People who show signs of TB outside the chest area, as judged by the investigator
  • People who completed a full course of TB treatment within the past 3 years
  • People who have had two or more separate episodes of TB in the past
  • People with a significant current or past medical condition that the trial team considers a safety risk
  • People living with HIV who are not yet on antiretroviral (HIV) medication, or have been on it for less than 3 months before screening
  • People living with HIV whose immune cell count (CD4+) is below 200 cells/uL at screening
  • People living with HIV whose virus level in the blood is above 200 copies/mL at screening
  • People living with HIV who have AIDS-defining infections or cancers
  • People whose blood test results at screening fall outside the acceptable ranges for liver enzymes (AST, ALT, or ALP), bilirubin, kidney function, red blood cells, white blood cells, neutrophils, or platelets (confirm specific values with trial site)
  • People who test positive for hepatitis B or hepatitis C
  • People with a blood sugar control reading (HbA1c) of 8.0% or higher
  • People currently taking or recently having taken immune-suppressing medications, including steroids
  • People with significant drug or alcohol use that could affect their safety or ability to follow the trial requirements
  • People who are pregnant, breastfeeding, have a positive pregnancy test, or are planning a pregnancy shortly after treatment

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 14 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: +1 857 702 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
14 April 2026
Est. completion
5 November 2026

Where this trial is recruiting

🇿🇦 South Africa

Primary endpoints

Bactericidal Activity; Safety: SAEs; Safety: TEAEs; Safety: AESIs; Safety: AEs leading to treatment discontinuation

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: 14 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