Medicine - Pediatrics
Diagnosis of active tuberculosis in HIV infected and uninfected young children in India
Tuberculosis (TB) is the most common cause of morbidity/mortality in HIV-infected individuals in India, which has among the world's highest burden of HIV and TB. Since children acquire HIV/TB from their caregivers, active TB is highly prevalent (14-67.5%) among HIV-infected young children in India - a vulnerable population, where lack of early detection/prevention of TB often has fatal consequences.Diagnosis of TB is particularly challenging in young children. Due to similar clinical presentation, active TB cannot be reliably distinguished from HIV (or co-infections). Tuberculin skin test (TST) is unreliable and bacterial confirmation (culture), when available, does not provide a diagnosis for weeks to months. TSPOT.TB is more sensitive/specific than TST for the diagnosis of active TB especially in young children with high rates of HIV, malnutrition, BCG vaccination and non-tuberculous mycobacteria (NTB). Microscopic observation drug-susceptibility (MODS) is a rapid assay for bacteriologic diagnosis of drug-susceptible and multi-drug resistant (MDR)-TB. Neither tests have been evaluated in the Indian setting, and the approach combining T-SPOT.TB and MODS, has never been tested previously.We will build on an existing Indo-US collaboration with Byramjee Jeejeebhoy Medical College (BJMC), and King Edward Memorial Hospital (KEM) in Pune, India. Inpatient/outpatient facilities at these centers serve children with high burden of HIVITB. In this study we will test the hypothesis that combined use of T-SPOT. TB and MODS will be non-inferior to current best standard of care for the diagnosis of active TB in young children in this region, but will have significantly reduced time to detection (including MDR- TB strains).
Amita Gupta, MD, School of Medicine; Robert Bollinger, MD, MPH, School of Medicine; Robert Gilman, MD, School of Public Health