Skip to main content

Table 3 Definition of the favorable and unfavorable outcomes in TB-TRUST study

From: Refining MDR-TB treatment regimens for ultra short therapy (TB-TRUST): study protocol for a randomized controlled trial

Outcome Description
Favorable outcome • A participant’s outcome will be classified as favorable if their last two culture results are negative unless they have previously been classified as unfavorable. These two cultures must be taken on separate visits (on different days); the latest of which being within the Week 84 window (that is no more than 6 weeks before 84 weeks since randomization but with no upper bound).
• Participants that don’t have a culture result within the Week 84 window because they were unable to produce sputum, will be classified as favorable if their last two cultures before the Week 84 window are negative and they have not previously been classified as unfavorable; such participants will be identified separately in tables.
Unfavorable outcome A participant’s outcome will be classified as unfavorable if:
• They are discontinued from their allocated study treatment and subsequently restarted on a different MDR-TB regimen;
• Treatment is extended beyond the scheduled end of treatment for any reason other than making up of days when no treatment was given (missed treatment) for a maximum of 8 weeks. A maximum of 14 days of extra treatment (irrespective of reason) is acceptable before it is classified as treatment extension. In addition, if the phase of treatment has been extended for delayed sputum conversion (maximum 8-week extension permitted) the scheduled end of treatment will also be extended by the same amount;
• They are restarted on any MDR-TB treatment after the scheduled end of treatment, but before 84 weeks after randomization;
• More than 1 drug has been changed for any reason;
• They die at any point during treatment or follow-up;
• At least one of their last two culture results, from specimens taken on separate occasions, is positive;
\