DMID 19-0005 Acute Flaccid Myelitis (AFM) Study

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

University of South Alabama
Mobile, AL

Arkansas 
Arkansas Children’s Hospital – Infectious Diseases
Little Rock, AR

California
University of Southern California
Los Angeles, CA

University of California, San Diego, Rady Children’s Hospital
San Diego, CA

UCSF Pediatrics, Benioff Children’s Hospital
San Francisco, CA

Stanford University
Stanford, CA

Colorado 
University of Colorado Health Science Center, Children’s Hospital Colorado
Denver, CO

District of Columbia 
Children’s National Medical Center
Washington, DC

Florida
University of South Florida Morsani College of Medicine
Tampa, FL

Georgia 
Emory Children’s Center
Atlanta, GA

Illinois
Lurie Children's Hospital of Chicago
Chicago, IL

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

Louisiana
Louisiana State University Health Sciences Center
Shreveport, LA

Maryland
Johns Hopkins University School of Medicine
Baltimore, MD

Massachusetts
Boston Children’s Hospital
Boston, MA

Minnesota
University of Minnesota
Minneapolis, MN

Mississippi 
University of Mississippi – Children’s Infectious Diseases
Jackson, MS

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

Nebraska 
Children’s Hospital, University of Nebraska Medical Center
Omaha, NE

New Jersey
The Children’s Hospital at St. Peters University Hospital
New Brunswick, NJ

New York 
Cohen Children’s Medical Center
Queens, NY

University of Rochester Medical Center
Rochester, NY

The State University of New York Upstate Medical University
Syracuse, NY

North Carolina
Carolinas Medical Center (Atrium Health) – Pediatrics – Infectious Diseases
Charlotte, NC

Ohio
Nationwide Children’s Hospital
Columbus, OH

Pennsylvania 
Children’s Hospital of Philadelphia and University of Pennsylvania School of Medicine
Philadelphia, PA

Children’s Hospital of Pittsburgh of UPMC – Pediatric Infectious Diseases
Pittsburgh, PA

South Carolina 
Medical University of South Carolina
Charleston, SC

Tennessee 
Vanderbilt University Medical Center
Nashville, TN

Texas 
Baylor College of Medicine - Texas Children's Hospital
Houston, TX

Cook Children’s Medical Center
Fort Worth, TX

Washington
Children’s Hospital and Regional Medical Center
Seattle, WA

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