Improving the management of hospitalized presumptive Xpert MTB/RIF-negative tuberculosis cases in Ethiopia

Project summary

Ethiopia is among the countries classified by the World Health Organization (WHO) as having a high burden of tuberculosis (TB). While great progresses have been made in TB diagnostics over the past decade, only 61% of cases have been bacteriologically confirmed, leaving empiric TB treatment initiated in 39% of cases. Empirical treatment is beneficial for patients with TB but does not reduce overall mortality and can even result in death if other highly sensitive diagnoses are overlooked. In addition, it remains unclear to what extent a clinical algorithm (consisting of antibiotic trial response and chest X-ray) and the role of empiric TB treatment in the management of presumptive Xpert-MTB/RIF-negative TB cases in Ethiopia.

Defining the performance of chest X-ray in the clinical prediction of active TB in hospitalized Xpert MTB /RIF-negative TB suspects is important to develop evidence-based guidelines. The value of the lateral flow urine lipoarabinomannan (LF-LAM) assay in the era of the highly sensitive Xpert MTB/RIF ultra assay is unclear, as well as the role of empirical TB treatment when Xpert MTB/RIF ultra-used as the initial diagnostic in presumptive TB cases is unknown. We propose to evaluate the ability of the existing clinical algorithms to accurately identify TB disease, the role of empiric TB treatment in patient survival, the added value of chest X-ray in identifying cases of active TB, the additional yield of LF-LAM assay when used in combination with Xpert MTB/RIF ultra, and the role of empiric TB treatment when Xpert MTB/RIF ultra-used as first line diagnosis in presumptive TB cases.