Prospective Longitudinal Study Design

How it works

Risks & contraindications

Background

Highlighted claims

• This is the first prospective longitudinal study to evaluate whether sputum LAM concentrations measured by PATHFAST-LAM predict clinical treatment outcomes in PTB. — Evaluating the PATHFAST TB LAM Ag assay as a treatment monitoring tool for pulmonary tuberculosis: protocol for a prospective longitudinal study in Nairobi, Kenya
• The study uses an adaptive design with an initial feasibility cohort of 300 participants, based on an expected poor-outcome rate of approximately 20% and a 15–20% allowance for loss to follow-up. — Evaluating the PATHFAST TB LAM Ag assay as a treatment monitoring tool for pulmonary tuberculosis: protocol for a prospective longitudinal study in Nairobi, Kenya
• The primary endpoint is the AUC representing the discriminatory performance of sputum LAM changes from baseline to week 4 and/or week 8 for the composite poor outcome. — Evaluating the PATHFAST TB LAM Ag assay as a treatment monitoring tool for pulmonary tuberculosis: protocol for a prospective longitudinal study in Nairobi, Kenya
• Whole-genome sequencing is performed on baseline and relapse isolates to differentiate true relapse from reinfection. — Evaluating the PATHFAST TB LAM Ag assay as a treatment monitoring tool for pulmonary tuberculosis: protocol for a prospective longitudinal study in Nairobi, Kenya
• Post-treatment follow-up is limited to 3 months by telephone, so late relapses will not be captured. — Evaluating the PATHFAST TB LAM Ag assay as a treatment monitoring tool for pulmonary tuberculosis: protocol for a prospective longitudinal study in Nairobi, Kenya
• Cost-effectiveness and feasibility for routine implementation are not formally assessed, as PATHFAST testing is performed by research staff rather than facility staff. — Evaluating the PATHFAST TB LAM Ag assay as a treatment monitoring tool for pulmonary tuberculosis: protocol for a prospective longitudinal study in Nairobi, Kenya