Project Details

STewardship for Acute Respiratory Illness (STAR): Expanding Access to Rapid Biomarker Testing

Emily Ciccone, MD, MHS

Summary

BACKGROUND: A key driver of global antimicrobial resistance is the inappropriate use of antibiotics, which are frequently prescribed to treat pediatric fever in resource-limited settings. However, ample data suggests that a large proportion of febrile illnesses, particularly those with respiratory symptoms, are caused by self-limited viral infections that do not require antibiotic therapy. GAP: There is an urgent need to improve the case management of pediatric acute respiratory illness (ARI) by non-physician providers, including community health workers (CHW), to whom the majority of children first present for care in rural, sub-Saharan Africa. HYPOTHESIS: The overarching scientific goal of this project is to demonstrate the feasibility and preliminary effectiveness of employing a rapid, point-of-care test for the clinical biomarker, C-reactive protein (CRP), to guide antibiotic treatment decisions by CHW for pediatric febrile ARI in rural Uganda. Our hypothesis is that we can safely reduce the proportion of children prescribed antibiotics by equipping CHW with these rapid diagnostic tests (RDT). METHODS: We will first compare the accuracy, cost, and ease-of-use of three CRP RDTs (Phase I). After selecting the best-performing RDT, we will conduct a stepped-wedge cluster randomized trial of its use to determine to whom antibiotics will be administered among children with malaria-negative, febrile ARI presenting to CHW for evaluation (Phase II). RESULTS: We compared two semi-quantitative CRP RDTs (BTNX Quad Line CRP, BTNX, Inc., Canada; Actim CRP, Medix Biochemica, Norway) to a lab-based, quantitative assay (Afinion CRP, Abbott, USA). Both RDTs demonstrated good agreement with the lab-based assay, although the Actim CRP had slightly better agreement than the BTNX (weighted kappa BTNX 0.62 (0.54, 0.70) v. Actim 0.70 (0.62, 0.79). The BTNX had slightly higher sensitivity but slightly lower specificity using CRP cut-offs of 40 mg/L. We therefore selected the Actim CRP as the RDT for Phase II of the study, the results of which are pending. IMPACT: To our knowledge, this would be the first study to equip CHW with an RDT other than the malaria RDT and evaluate its impact on antimicrobial use. Given the vast burden of pediatric acute respiratory illness and expanding role CHW are playing in the initial care of children, our results could have a significant impact on global antibiotic use. Optional/Additional Comments: This work will be conducted in collaboration with Dr. Edgar Mulogo, Associate Professor and Chair of the Department of Community Health at the Mbarara University of Science and Technology in Mbarara, Uganda.

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