A study outcome occurred: Active TB develops before the 24 Visit; the participant may enroll into Cohort A if all eligibility criteria are met; or Completion of the Month 24 Visit. Participants in Cohort A or Cohort B will be discontinued from the study for any of the following reasons: The participant/parent/legal guardian withdraws consent and/or assent; The participant is lost to follow-up or moves out of the area; The participant dies; The participant was inadvertently enrolled; The investigator determines that further participation would be detrimental to the health or well-being of the participant; The is stopped by a funding organization or other government agency; or The study has to stop for other administrative reasons. 7. Sample Size [this section will be modified based on host country sample size plans] The primary objective of the study is to provide specimens to biomarker researchers and their collaborators for investigations intending to lead to a better understanding of the prognosis of TB disease and the pathogenesis of progression from TB exposure to active disease. To address this primary objective, biospecimens will be over time from two prospective, “banked” observational cohorts, one with participants who have active pulmonary TB (Cohort A) and the second with participants who are HHCs of an active case of TB (Cohort B). A range of possible outcomes for use in research studies has already been described. In addition, general information will be collected on study participants, including demographic, medical history, clinical data, CBC and lymphocyte counts, HbA1c, HIV testing status, and for those that are determined to be HIV-positive at the time of specimen collection, their CD4 count will be
A study outcome occurred: Active TB develops before the 24 Visit; the participant may enroll into Cohort A if all eligibility criteria are met; or Completion of the Month 24 Visit. Participants in Cohort A or Cohort B will be discontinued from the study for any of the following reasons: The participant/parent/legal guardian withdraws consent and/or assent; The participant is lost to follow-up or moves out of the area; The participant dies; The participant was inadvertently enrolled; The investigator determines that further participation would be detrimental to the health or well-being of the participant; The is stopped by a funding organization or other government agency; or The study has to stop for other administrative reasons. 7. Sample Size [this section will be modified based on host country sample size plans] The primary objective of the study is to provide specimens to biomarker researchers and their collaborators for investigations intending to lead to a better understanding of the prognosis of TB disease and the pathogenesis of progression from TB exposure to active disease. To address this primary objective, biospecimens will be “banked” over time from two prospective, observational cohorts, one with participants who have active pulmonary TB (Cohort A) and the second with participants who are HHCs of an active case of TB (Cohort B). A range of possible outcomes for use in research studies has already been described. In addition, general information will be collected on study participants, including demographic, medical history, clinical data, CBC and lymphocyte counts, HbA1c, HIV testing status, and for those that are determined to be HIV-positive at the time of specimen collection, their CD4 count will be
RePORT-International-Common-Protocol-V1.1-12Jan16-Template.docx