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BIRMINGHAM - National Institute of Allergy and Infectious Disease, part of the National Institutes of Health, has awarded the University of Alabama at Birmingham Department of Pediatrics at Children’s of Alabama a $10 million contract to conduct a multicenter, multinational natural history study of acute flaccid myelitis (AFM) in pediatric patients.
UAB will be co-leading the study with Johns Hopkins University School of Medicine. The study is anticipated to begin enrollment in August 2019 to correspond with this year’s predicted outbreak cycle, which typically is in the summer and fall. In past years, the largest pattern of outbreaks occurred in this seasonal window.
AFM is a rare but serious condition referred to as a “polio-like” illness for the way it affects a child’s nervous system and causes their muscles and reflexes to become weakened. It is suspected that many common viruses — including enteroviruses — play a role in the spread of AFM, but there are no identified causes or proven therapies for AFM.
“Since at least 2014, children have been at risk of developing a polio-like syndrome likely due to enteroviruses, and this study will provide the basis for understanding the cause of those children’s paralysis,” said David Kimberlin, M.D., co-director of the UAB Division of Pediatric Infectious Diseases at Children’s and co-principal investigator of the study. “Knowledge gained from this study hopefully will provide the foundation for future treatment studies of antiviral drugs. We hope to better understand why acute flaccid myelitis occurs and which children are most at risk, and to develop the biorepository and associated clinical database to understand what we can do about it in the future.”
The five-year natural history study will occur at 38 or more sites across the United States, Canada, the United Kingdom and Peru, and will review serious and life-threatening viruses in pediatric populations that could be connected to AFM cases.
“The major problem with AFM as a public health threat is not only the emergence of hundreds of cases around the United States and the world, but the fact that AFM produces devastating and longstanding neurological problems for affected children,” said Carlos A. Pardo-Villamizar, M.D., director of the Johns Hopkins Hospital Myelitis Center and co-principal investigator of the study on behalf of the AFM Task Force, a multidisciplinary and multicenter collaborative group of clinicians and scientists. “Thus, there is an urgent need for a concerted collaborative effort around the country to tackle the problem with the best research tools available to develop better options for diagnosis and treatment and, most importantly, to help children and families affected by this devastating neurological disorder.”
In developing the research study, UAB and Johns Hopkins researchers have worked closely with the National Institutes of Health, the Centers for Disease Control and Prevention, and investigators at many of the study sites to ensure that it meets both the scientific and public health objectives of the national response to AFM.