EXULTANT Trial: Improving Tuberculosis Diagnosis in HIV-Positive Hospitalized Patients
Overview
The EXULTANT trial aims to evaluate a new screening strategy for diagnosing tuberculosis (TB) in hospitalized people living with HIV (PLHIV) in Tanzania and Mozambique. The trial focuses on the impact of using multiple specimens (sputum, stool, and urine) for TB diagnosis, along with urine lipoarabinomannan lateral flow (LF-LAM) testing, regardless of TB symptoms.
Methods
The trial is a multicenter, randomized controlled trial conducted across eleven hospitals. The intervention arm will use Xpert MTB/RIF Ultra® testing from multiple samples, along with urine LF-LAM testing, while the control arm will follow WHO standard recommendations. Eligible participants are hospitalized adults with confirmed HIV diagnosis, and the primary endpoint is the proportion of participants with microbiologically confirmed TB starting treatment within 3 days of enrollment.
Discussion
The trial aims to rapidly implement a new diagnostic algorithm using Xpert MTB/RIF Ultra® and LF-LAM testing in hospitalized PLHIV, with the goal of detecting frequently missed TB cases and evaluating the intervention’s scalability.
Trial Registration
Trial reference number: NCT04568967 (ClinicalTrials.gov) registered on 2020-09-29.
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