A Prospective Study of Acute Flaccid Myelitis (AFM) to Define Natural History, Risk Factors and Pathogenetic Mechanisms

Click here to view the AFM-DMID 19-0005 Study Initiation Webinar, 21-NOV-2019

The overall objective of the NIAID-funded study is to create a biorepository of specimens and associated clinical and outcome data for use in future studies of AFM, including virologic or immunologic assessments.

The University of Alabama at Birmingham (UAB) is coordinating and implementing the study and is also opening the first clinical study site.

Brief Summary: AFM is a rare but serious neurologic disease characterized by sudden muscle weakness and paralysis. It appears to occur mostly in children, often following a mild respiratory illness. As of August 2, 2019, 574 confirmed cases of AFM had been reported in the United States since August of 2014.

Study Description: Patients with suspected AFM (onset of flaccid limb weakness within the previous 30 days) are eligible to enroll in the study. Investigators will assess participants at four-time points within the first month of enrollment and will ask participants to return for additional follow up visits at 3 months, 7 months and 1 year. Neurologic improvements will be tracked over time, and samples will be collected and stored in a biorepository for use in future research studies. Household contacts, such as siblings, will be eligible to participate in the study as a control or comparison group.

Additional clinical research sites in the U.S., Canada, the United Kingdom, and Peru are expected to open in the coming months.

Contacts: David W Kimberlin MD, 205-934-5316, dkimberlin@peds.uab.edu

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

A list of potential study locations to be opened are shown below. For all sites please contact Dr. Kimberlin’s office (dkimberlin@peds.uab.edu or sdavis@peds.uab.edu) and the Central Unit personnel will be able to provide more current information for these study locations.

United States, Alabama – Children’s of Alabama – UAB Hospital (open as of 8.23.19)

            Birmingham, AL

United States, Alabama – University of South Alabama

            Mobile, AL

United States, Arkansas – Arkansas Children’s Hospital – Infectious Diseases

            Little Rock, AR

United States, California – University of Southern California

            Los Angeles, CA

United States, California – Children’s Hospital of Orange County

            Orange, CA

United States, California – University of California, San Diego, Rady Children’s Hospital

            San Diego, CA

United States, California – Kaiser Permanente San Francisco Medical Center and UCSF Pediatrics, Benioff Children’s Hospital

            San Francisco, CA

United States, California – Stanford University

            Stanford, CA

United States, Colorado – University of Colorado Health Science Center, Children’s Hospital Colorado

            Denver, CO

United States, District of Columbia – Children’s National Medical Center

            Washington, DC

United States, Florida – University of South Florida Morsani College of Medicine

            Tampa, FL

United States, Georgia – Emory Children’s Center

            Atlanta, GA

United States, Kentucky – University of Louisville School of Medicine – Norton Children’s Hospital

            Louisville, KY

United States, Louisiana – Louisiana State University Health Sciences Center

            Shreveport, LA

United States, Maryland – Johns Hopkins University School of Medicine

            Baltimore, MD

United States, Massachusetts – Boston Children’s Hospital

            Boston, MA

United States, Minnesota – University of Minnesota

            Minneapolis, MN

United States, Mississippi – University of Mississippi – Children’s Infectious Diseases

            Jackson, MS

United States, Missouri – Washington University School of Medicine in St. Louis – Center for Clinical Studies

            St. Louis, MO

United States, Nebraska – Children’s Hospital, University of Nebraska Medical Center

            Omaha, NE

United States, New Jersey – The Children’s Hospital at St. Peters University Hospital

            New Brunswick, NJ

United States, New York – Cohen Children’s Medical Center

            Queens, NY

United States, New York – University of Rochester Medical Center

            Rochester, NY

United States, New York – The State University of New York Upstate Medical University

            Syracuse, NY

United States, North Carolina – Carolinas Medical Center (Atrium Health) – Pediatrics – Infectious Diseases

            Charlotte, NC

United States, Ohio – Nationwide Children’s Hospital –

            Columbus, OH

United States, Pennsylvania – Children’s Hospital of Philadelphia and University of Pennsylvania School of Medicine

            Philadelphia, PA

United States, Pennsylvania – Children’s Hospital of Pittsburgh of UPMC – Pediatric Infectious Diseases

            Pittsburgh, PA

United States, South Carolina – Medical University of South Carolina

            Charleston, SC

United States, Tennessee – Vanderbilt University Medical Center

            Nashville, TN

United States, Texas – University of Texas Southwestern Medical Center

            Dallas, TX

United States, Texas – Cook Children’s Medical Center

            Fort Worth, TX

United States, Washington – Children’s Hospital and Regional Medical Center

            Seattle, WA

United States, Wisconsin – Children’s Hospital of Wisconsin-Milwaukee

            Milwaukee, WI

Canada, Ontario – The Hospital for Sick Children (Sickkids), University of Toronto

            Toronto, Ontario, Canada

United Kingdom – Sites to Be Determined

Peru – Sites to Be Determined

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