Comparing 3 approaches for latent tuberculosis infection

Exclusion

• −Children aged 0-4 years;
• −Rifampin or rifapentine contra-indicated - due to allergy/hypersensitivity to any rifamycin (rifampin, rifabutin or rifapentine), or, drug interactions too difficult to manage;
• −Current tuberculosis (TB) disease - detected pre-enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → 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
• −Persons weighing \<15 kg.
• −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 eventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AE);
• −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-randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →, 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.
• −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;