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โ† Trials
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Shorter and Safer Treatment Regimens for Latent TB

RecruitingPhase 2, Phase 3Ages 5 Years - anyAllMcGill University Health Centre/Research Institutโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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 superior with respect to acceptance, completion, and costs; 3. 4 months of Rifampin 10mg/kg (4R10) is the safest regimen, but is completed by \<80% of patients; 4. The safety of 2 months of Rifampin 20mg/kg (2R20) is similar to that of 4 months of Rifampin 10mg/kg (4R10), but completion is a concern; 5. 1-month regimens have promising efficacy; 6. Safety and tolerability must be carefully assessed with comparisons to 4 months of Rifampin 10mg/kg (4R10), and head-to-head with each other. OBJECTIVES: The investigator will use a Bayesian adaptive Phase 2 randomized open-label trial design to test at least three experimental Tuberculosis Preventive Treatment (TPT) regimens to identify at least one r

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adults, and children aged โ‰ฅ5 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.
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What it tests

  • rifampin standard arm
  • rifampin double dose
  • levofloxacin and rifapentine
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Where

14 sites
Centre National Hospitalier Universitaire de Pneumo Phtisiologie de Cotonou (CNHU-PPC)
Cotonou, Benin
Manaus
Manaus, Brazil
Unviversity of Calgary
Calgary, Canada
The Governors of the University of Alberta
Edmonton, Canada
BCCDC TB clinic
Vancouver, Canada
University of Manitoba
Winnipeg, Canada
University of Ottawa
Ottawa, Canada
St. Michael's Hospital
Toronto, Canada

โ€ฆand 6 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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