Table 4.
Triggers and Procedures for Participants with Possible Poor Treatment Response (PPTR)
| A PPTR evaluation is triggered by any one or more of the following, and applies to all regimens: |
| • A positive culture confirmed as M. tuberculosis from a sputum specimen collected at or after week 17 |
| • A positive smear from a sputum specimen collected at or after week 17 |
| • Worsening signs and/or symptoms consistent with tuberculosis at or after week 17 |
| • Radiographic worsening consistent with tuberculosis at or after week 17 |
| • The site investigator is considering an extension of tuberculosis treatment beyond that of the participant’s assigned regimen |
| • The site investigator is considering re-treatment with any tuberculosis therapy after the participant has completed their assigned regimen |
| • For a participant on assigned study treatment, the site investigator is considering a change in treatment for efficacy reasons (this does not apply to changes in treatment for pregnancy, temporary drug challenge, or toxicity) |
| Study procedures implemented for all participants who have a PPTR trigger: |
| • Symptom assessment |
| • Review interval medical history |
| • Concomitant medical assessment |
| • Measure weight |
| • Obtain at least 3 sputum specimens and send them to the study laboratory for smear and culture. At least two of these specimens should be obtained prior to changing or re-starting tuberculosis treatment (if change or re-start are being considered), and at least 4 hours apart. At least one of the specimens should be a first morning specimen, if feasible. If M. tuberculosis is isolated in culture, then DST should be performed, and the isolate stored frozen. |
| • Chest radiograph |
| • For participants consenting to collection of specimens for biomarker research, sputum, urine, and blood should be obtained |
| • Review participant’s contact information |
| • Complete the appropriate case report form |
| • Contact the Study Clinician to review PPTR procedures and ensure that all procedures are completed |
| • Participant should continue to be followed in the study per the Protocol/Manual of Operating Procedures unless participant withdraws consent |