Phase 3 Tuberculosis Trial, Recruiting NCT06498414 Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre Condition: Tuberculosis
Back to Tuberculosis

Phase 3 Tuberculosis Trial, Recruiting

NCT06498414
Recruiting Phase 3

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:

  • Adults, and children aged 5 years or older who weigh more than 15 kg (about 33 pounds)
  • People who have tested positive for TB infection, either through a skin test (tuberculin test) or a blood test (interferon gamma release assay), interpreted according to local guidelines
  • People whose doctor has recommended preventive TB treatment, following Canadian guidelines (for sites in Canada) or World Health Organization guidelines (for sites in other countries)

Who may not be able to join:

  • People who currently have active TB disease, confirmed through symptom checks, chest X-ray, and laboratory testing as needed
  • Children aged 0 to 4 years
  • People who weigh less than 15 kg (about 33 pounds)
  • Women who are currently pregnant or breastfeeding
  • Women who are able to become pregnant but are not willing to use an effective non-hormonal form of contraception during the treatment period
  • People who have previously been treated for TB infection or TB disease
  • People whose pre-enrolment blood test results show seriously abnormal liver function (ALT), white blood cell count, platelet levels, or haemoglobin levels (classified as Grade 3 or above)
  • People for whom the antibiotics rifampin or rifapentine are not suitable — for example, due to an allergy or sensitivity to any rifamycin-type antibiotic (rifampin, rifabutin, or rifapentine), or because of drug interactions that cannot be safely managed
  • People who have an abnormally long QT interval on a routine heart tracing (ECG) before joining, or who take certain medications that can affect heart rhythm and are not safe to take alongside levofloxacin (confirm with trial site for the specific medication list)
  • People who are close household contacts of a TB patient whose TB has been found to be resistant to rifampin or levofloxacin

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 21 July 2026
Phase 3: approximately ~65% 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: Dick Menzies, MD, RI-MUHC

Phone: 514-934-1934

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 3
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Registry
ClinicalTrials.gov
Start date
10 June 2025
Est. completion
1 April 2027

Where this trial is recruiting

Benin 🇧🇷 Brazil 🇨🇦 Canada 🇮🇩 Indonesia 🇻🇳 Vietnam

Primary endpoints

Severe treatment-related Adverse Events (AE)

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: 21 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