Shorter, Safer Preventive Treatment for Latent TB

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open‑label, multi‑arm Bayesian adaptive Phase 2/3 trial comparing the reference regimen of 4 months rifampin 10 mg/kg (4R10) to at least two experimental shorter regimens (2 months rifampin 20 mg/kg [2R20] and one month levofloxacin plus rifapentine [1LP]) with a possible third one‑month regimen added later. Regimens that fail pre‑specified safety, completion, or tolerability criteria will be dropped and randomization will be adjusted to prioritize promising arms. Primary outcomes are safety, treatment completion, and tolerability in adults and children aged ≥5 years who are eligible for tuberculosis preventive treatment. The protocol includes informed consent updates and ethics review when a new experimental regimen is added.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults, and children aged ≥5 years with weight of \> 15Kg.
* Positive test for TB infection: either Tuberculin test (\>5mm, or \>10mm, based on epidemiologic and clinical factors and interpreted following local guidelines) or interferon gamma release assay based on Manufacturer's criteria; and,
* Recommended for Tuberculosis Preventive Treatment (TPT), following Canadian guidelines (for Canadian sites), and World Health Organization (WHO) guidelines (for international sites).

Exclusion Criteria:

* Current tuberculosis (TB) disease - detected pre-enrolment with symptom screen, chest x-ray, and confirmatory microbiological (culture or genotypic) testing as needed; Prior to referral to research staff (research clinic) for consideration as potential participants, all persons must undergo symptoms screen and a chest Xray. If chest Xray is not available, then a negative results from a GeneXpert MTb RIF Ultra of spontaneous (expectorated) sputum will be considered sufficient to exclude TB disease pre-referral. If Chest Xray is abnormal or symptoms consistent with TB disease are present then at least two AFB smears and mycobacterial cultures must be done, and must be negative, or one GeneXpert MTb Rif Ultra must be negative before enrolment
* Children aged 0-4 years;
* Persons weighing \<15 kg.
* Women who are pregnant or breast-feeding;
* Women of child-bearing potential and not willing to take an effective form of contraception (non-hormonal) during the treatment phase;
* Documented prior treatment for tuberculosis (TB) infection or disease;
* Pre-enrolment - alanine transaminase (ALT), White Blood Cells, platelets or hemoglobin that correspond to a Grade 3 adverse event (AE);
* Rifampin or rifapentine contra-indicated - due to allergy/hypersensitivity to any rifamycin (rifampin, rifabutin or rifapentine), or, drug interactions too difficult to manage;
* Have a prolonged QT interval on routine ECG pre-enrolment or take any medications that may prolong the QT interval and that are not recommended to take with a fluroquinolone. (See APPENDIX 5 in supplement for list of medications contra-indicated to take with Levofloxacin);
* Household contacts (HHC) of index TB patients with phenotypic or genotypic resistance to Rifampin or Levofloxacin. HHC may be enrolled, then excluded post-randomization, if resistance is identified later. Note that all sites routinely test Rifampin resistance in all people newly diagnosed to have TB disease, but do not test routinely for susceptibility to Levofloxacin unless Rifampin resistance is detected. Hence HHCs may be enrolled if their Index TB patient is Rifampin susceptible, even if Drug Susceptibility Testing to Levofloxacin is not done and/or not available.

Where it's running

• Manaus
  Manaus, Brazil Recruiting
• Unviversity of Calgary
  Calgary, Alberta, Canada Recruiting
• The Governors of the University of Alberta
  Edmonton, Alberta, Canada Recruiting
• BCCDC TB clinic
  Vancouver, British Columbia, Canada Recruiting
• University of Manitoba
  Winnipeg, Manitoba, Canada Recruiting
• University of Ottawa
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Dick Menzies, MD — Ri-Muhc
• Study coordinator: Dick Menzies, MD
• Email: dick.menzies@mcgill.ca
• Phone: 514-934-1934

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.