First participant enrolled in study of IV artesunate to treat children with severe malaria in Uganda

This late phase study of intravenous (IV) artesunate to treat children with severe malaria is being conducted to determine the relationship between dihydroartemisinin (DHA) exposures following IV artesunate dosing and markers of physiologic dysfunction associated with severe malaria in Ugandan children. The single-site study is being conducted at the Makerere University Infectious Disease Institute in Uganda, a University of Maryland Vaccine Treatment and Evaluation Unit (VTEU)-affiliated site, in partnership with the Infectious Diseases Clinical Research Consortium (IDCRC).

“The study assesses biophysical parameters to inform if current dosing can be further optimized to achieve maximum curative efficacy. This study is timely and relevant given reports of the recent emergence of partial resistance to artemisinin in Africa,” says Matthew B. Laurens, MD, MPH, Professor of Pediatrics, Director of the International Clinical Trials Unit, Malaria Research Program at the Center for Vaccine Development and Global Health (CVD), University of Maryland School of Medicine, and the study’s principal investigator (PI).

Laurens is a pediatric infectious disease specialist with a primary research interest in malaria, typhoid fever, and other diseases that disproportionately affect people who live in resource-limited settings. He conducts studies at the CVD in Baltimore and at international sites in Burkina Faso, Mali, Malawi, and Uganda. Laurens evaluates vaccines and therapeutics that target infectious pathogens, studies the interaction of HIV and malaria and investigates the acquisition of antimalarial immunity. The broad goal of his research is to illuminate the mechanisms of vaccine-induced immunity with the aim to inform development of vaccines and therapeutics.

 This clinical study is a phase 4, open-label pharmacokinetic study of IV artesunate in up to 100 Ugandan children, 6 months-14 years of age, who are diagnosed with severe malaria according to standardized World Health Organization (WHO) criteria. Participants receive the standard of care IV artesunate for initial treatment of severe malaria. IV treatment will be administered for a minimum of 24 hours, after which patients will be evaluated clinically and assessed for ability for oral intake of antimalarials. Children who can transition to oral antimalarial therapy will initiate a three-day course of artemisinin-combination oral therapy per national guidelines.

 Visit for additional details. The study is being conducted in partnership with the IDCRC and the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health.

About Infectious Disease Clinical Research Consortium (IDCRC)

The IDCRC, consisting of the Vaccine Treatment and Evaluation Units (VTEUs) and the IDCRC Leadership Group (UM1AI148684), was formed in 2019 to support the planning and implementation of infectious diseases clinical research that efficiently addresses the scientific priorities of NIAID. The consortium includes infectious diseases leaders and clinical researchers from Emory University, University of Maryland School of Medicine, Baylor College of Medicine, Cincinnati Children’s Medical Center and University of Cincinnati, FHI360, Fred Hutchinson Cancer Research Center, Johns Hopkins University, Kaiser Permanente Washington Health Research Institute, New York University, Saint Louis University, Vanderbilt University Medical Center, University of Alabama at Birmingham, University of Rochester, University of Washington, and NIAID. View other IDCRC studies

About the University of Maryland School of Medicine Vaccine Treatment and Evaluation Unit (VTEU)

NIAID established the VTEUs in 1962 as a consortium comprising centers of excellence for conducting clinical trials to develop new and improved vaccines and therapies against infectious diseases. University of Maryland School of Medicine (UMSOM) investigators have been the recipients of this award for over four decades (current award number 5UM1AI148689) and have conducted hundreds of clinical trials to develop products that can be used to reduce disease burden and to counteract existing and emerging public health threats. With a focus on bringing vaccines to underserved populations globally, the VTEU performs international studies of vaccines to prevent the major killers of children in the world, including malaria, meningitis, diarrheal disease, and pneumonia. With its rapid response capability, the VTEU at UMSOM plays leadership roles in pivotal trials that support approval and licensure of vaccines and therapeutics to control pandemics including the 2009 swine flu and COVID-19. Other trials have strengthened the national stockpile of vaccines to prevent infections that could be used as a bioterrorist weapon against the U.S., such as smallpox and anthrax. Innovative strategies are used to expand the array of pathogens that can be prevented with vaccines, and to improve delivery, strengthen effectiveness, and expand supply and access to these life-saving measures. The VTEU at UMSOM conducted the first clinical study of an edible vaccine that that might protect against travelers’ diarrhea, evaluated numerous needle-free vaccine administration strategies, developed combination vaccines so fewer inoculations could prevent more infections, and tested a topical antibiotic to prevent serious infections among critically ill infants. The broad opportunities provided by the VTEU have contributed to the training of generations of vaccinologists.