Mpox is a disease caused by a virus in the smallpox family. Endemic in central and west Africa, mpox symptoms are generally less severe and rarely fatal relative to smallpox. But a global outbreak in the Spring of 2022– including an alarming spike in reported cases in the U.S. – prompted the U.S. Department of Health and Human Services to declare a public health emergency and launch prevention and treatment studies and other rapid response initiatives to address the spread of mpox.
With no existing Food and Drug Administration-approved treatment for mpox, federal agencies approved a phase 3 clinical trial—the Study of Tecovirimat for Human Monkeypox Virus (STOMP)—to determine the effectiveness of treating mpox with tecovirimat (TPOXX), the FDA-approved antiviral treatment for smallpox.
Enter the UCLA-affiliated AIDS Clinical Trials Group (ACTG) to lead the study. ACTG reached out to Medline for help with STOMP implementation requirements and the significant challenges associated with collecting samples across 70+ trial locations around the U.S. and abroad against an accelerated timeline.
The Medline Newsroom asked Kathie Ferbas, PhD, scientific lead, ACTG Lab Center and Timothy Wilkin, MD, MPH, ACTG protocol chair, about the STOMP launch.