Status:
NOT_YET_RECRUITING
Shorter and Safer Treatment Regimens for Latent TB
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Tuberculosis Infection, Latent
Eligibility:
All Genders
5+ years
Phase:
PHASE2
PHASE3
Brief Summary
Our study rationale is based on: 1. Tuberculosis Preventive Treatment (TPT) is given to healthy people and needs to be safe; 2. Tuberculosis Preventive Treatment (TPT) with shorter regimens are super...
Detailed Description
DESIGN: The investigator proposes to assess safety, completion, and tolerability of three experimental Tuberculosis Preventive Treatment (TPT) regimens in an open label multi-arm Phase 2 adaptive tria...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT06498414
Start Date
June 9 2025
End Date
June 1 2029
Last Update
June 10 2025
Active Locations (13)
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1
Centre National Hospitalier Universitaire de Pneumo Phtisiologie de Cotonou (CNHU-PPC)
Cotonou, Benin
2
Manaus
Manaus, Brazil
3
Unviversity of Calgary
Calgary, Alberta, Canada
4
The Governors of the University of Alberta
Edmonton, Alberta, Canada, T6G 2C8