Evaluation of PATHFAST-LAM as a Tuberculosis Treatment Monitoring Tool in Kenya

Launched by NAGASAKI UNIVERSITY ·

Keywords

ClinConnect Summary

This study in Nairobi, Kenya is looking at a new way to monitor how well pulmonary tuberculosis (TB) treatment is working. Researchers will use a test called PATHFAST-LAM, which checks for a substance (LAM) in sputum and urine. They want to see if changes in LAM levels during treatment can predict whether someone will have a poor outcome, such as death, stopping treatment for a long time, relapse after finishing treatment, changing the TB regimen, or not showing the expected lab improvement by the end of treatment.

Eligible participants are adults (18 and older) with newly diagnosed, bacteriologically confirmed pulmonary TB who have not yet started treatment and can attend follow-up visits and give informed consent. People who recently had TB treatment (in the last 6 months) are not eligible. About 300 participants are planned; an initial 30-person check will help finalize numbers. Participants will be enrolled at two facilities (Mbagathi County Referral Hospital and Rhodes Chest Clinic) and will provide sputum and urine samples starting at baseline, then throughout 6 months of treatment (weekly for month 1, every 2 weeks for months 2–3, then monthly). The study is sponsored by Nagasaki University and led by Nobuo Saito. The trial is not yet recruiting, with sites expected to start around January 2026 and finish around July 2027.

Gender

ALL

Eligibility criteria