NCT04568967

TB-CAPT EXULTANT - HIV

Expanding Xpert Ultra Testing for TB Diagnosis Among HIV-positive Patients Admitted to Hospital in Africa

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,172 (actual)
• Sponsor: Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall aim of this study is to assess the potential of an expanded TB testing strategy to increase the number of HIV-positive patients with microbiologically diagnosed TB who are started on treatment in adult wards of sub-Saharan Africa.

Detailed description

To investigate the effect of an expanded TB screening strategy among HIV-positive patients admitted to hospital (including Ultra on sputum, stool and urine, and AlereLAM on urine, performed regardless of presence of TB symptoms) on the proportion of microbiologically-confirmed TB cases starting treatment within 72 hours of enrolment, compared to Ultra testing (on sputum/any tissue) and AlereLAM (on urine) in only those patients who are symptomatic for TB or fulfilling WHO testing recommendations. to assess the impact of this screening strategy on 2-month all-cause mortality. • to assess the feasibility of multiple specimens' collection for TB diagnosis within 72 hours of enrolment.

Conditions

• Tuberculosis
• HIV Coinfection
• Diagnoses Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Concentrated urine with Xpert Ultra	Molecular TB diagnostic test on urine
DIAGNOSTIC_TEST	Stool with Xpert Ultra	Molecular TB diagnostic test on stool

Timeline

• Start date: 2022-09-05
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2020-09-29
• Last updated: 2025-04-04

Locations

4 sites across 2 countries: Mozambique, Tanzania