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Project Details

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.

Summary

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.

RESULTS: Pending

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.

Keywords:
Drug Resistance, Tuberculosis, HIV, Prospective Cohort, Diagnosis, Human










Supervising Institution:
Children's Mercy Hospital

Project Location:
United States, South Africa

Award Amount:
$196,356

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