Article Text
Abstract
Background Tuberculosis (TB) diagnosis is challenging in children, particularly in infants, contributing to high TB-related mortality. Up to 30% of infants with pulmonary TB have concurrent extrapulmonary disease, with findings that can frequently be detected with ultrasound. A protocol of focused assessment with sonography for HIV-associated TB (FASH) at six abdominal and thoracic positions has shown promise for diagnosis in children and adults, but few infants have been included in published studies.
Methods EMPIRICAL (#NCT03915366) is a randomized, controlled trial funded by EDCTP (RIA2017MC-2013) recruiting HIV-positive infants <12 months hospitalized with severe pneumonia without current/past TB diagnosis or exposure. All participants have Xpert Ultra (stool, nasopharyngeal aspirate) and urine LAM testing, and in an ongoing blinded diagnostic ancillary study at 5 hospitals in Mozambique, FASH is performed. An interim descriptive analysis was done for participants no longer active in the trial as of April 2023.
Results For the 39 participants included, the median age was 3 months (IQR:3.17–5.13), 48.7% were female, and the median CD4% was 13% (IQR:9.90–17.55). There was ≥1 positive FASH finding in 10/39 (25.6%); all had pericardial effusion 10/39 (25.6%), with focal splenic lesions and ascites also noted in 2/39 (5.1%) and 1/39 (2.6%), respectively. No participants had pleural effusion, focal liver lesions, or abdominal lymphadenopathy. In participants with laboratory-confirmed TB, 42.9% (3/7) had ≥1 positive FASH finding. There were 2 positive FASH findings in 7.6% (3/39) participants, of whom 66.7% (2/3) had laboratory-confirmed TB.
Conclusion Positive FASH findings were frequent in HIV-positive infants hospitalized with severe pneumonia and even more common in the subset of participants with laboratory-confirmed TB, with pericardial effusion noted on all positive FASH exams. Future analysis will attempt to define which abnormalities on FASH exam are most predictive of TB disease and assess the use of FASH to monitor TB treatment response.