E.W. "Al" Thrasher
Status: Funded - Open
Pediatric tuberculosis-enabling early detection of children at-risk for poor treatment outcomes
Susan Abdel-Rahman, Pharm.D.
BACKGROUND: Globally, 10% of TB cases occur in children; however, this number rises to 20-40% in low-income, high-burden countries. For children unfortunate enough to acquire drug-resistant TB (DR-TB); treatment lasts more than twice as long as traditional therapy, costs 10x as much, and is accompanied by an 83-fold greater risk of treatment failure.
GAP: A big concern surrounding the treatment of children with DR-TB are treatment guidelines that are driven by data which are incomplete or absent. Though investigators are making concerted efforts to address this data gap by conducting PK studies of anti-TB drugs in children, a persistent limitation of these studies is that the dose-exposure relationships observed in well-conducted trials do not always predict the dose-exposure relationships observed “in the field.”
HYPOTHESIS: Dried blood spots (DBS) can be used to facilitate TB drug monitoring in resource-constrained settings.
METHODS: Develop DBS assays for the primary drugs used to treat DR-TB and field-test the technology in an “ideal” treatment setting where venous blood concentrations are already planned thus, affording the opportunity for clinical and bioanalytical validation of the assays.
IMPACT: TB drug monitoring can provide point-of-care clinicians with objective data to guide treatment in the children for whom they care. DBS assays will not only enhance clinical care but enable the conduct of population-based PK studies in children for whom we have no information on the relationship between dose and exposure.
Drug Resistance, Tuberculosis, HIV, Prospective Cohort, Diagnosis, Human
Children's Mercy Hospital
United States, South Africa