January 17, 2024
The Austere environment Consortium of Enhanced Sepsis Outcomes (ACESO) and the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) are pleased to announce the enrollment of the first participant in the protocol “An Observational Study of Sepsis and Acute Febrile Illness in Madagascar”. Madagascar is the newest site in the ACESO global research network.
In 2021, as part of its Outbreak Clinical Trials program funded by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), ACESO set out to identify and set up a clinical research site in Madagascar to support the deployment of early phase clinical trials for medical countermeasures against Yersinia pestis (plague) developed through JPEO-CBRND’s antibody pipeline program. Madagascar was chosen as the country experiences annual, seasonal outbreaks of plague.
Leveraging its previous outbreak clinical experience in Uganda at the Fort Portal site, which was also DOD funded, ACESO established a collaboration with the Madagascar Ministry of Health, its primary infectious disease hospital in the capital, Centre Hospitalier Universitaire Joseph Raseta Befelatanana, and the Centre D’Infectiologie Charles Merieux. The ACESO team made several trips to Madagascar to identify key areas to support the development of a clinical trial-ready research site. Renovations to an existing building on the hospital campus for a point of care laboratory and dedicated research space were completed in late 2023. Research staff including medical officers, laboratory technicians, study nurses and clinical monitor have been hired and trained.
ACESO, in collaboration with Duke University, supported the augmentation of laboratory and microbiology testing capacity in the hospital with the addition of point of care coagulation equipment, along with automated instruments for hematology and blood culture identification. Pathogen identification capacity was also expanded with the addition of BioFire FilmArray Global Fever Panel, Cepheid GeneXpert tuberculosis cartridge and other rapid diagnostic tests. The Fort Portal team and ACESO staff conducted laboratory staff training and assisted in establishing essential documentation needed for clinical trial readiness. ACESO also rolled out their new biological specimen inventory management system, BSI Systems, allowing for biobanking sample recording with quality control and audit features.
The first phase of the research collaboration with Madagascar is the implementation of the observational study of participants with severe infections, leveraging the clinical research expertise, clinical protocol, database, and procedures developed by ACESO for studies of participants with sepsis. The observational study will serve as both a training platform for clinicians and laboratorians, as well as a research platform to evaluate technologies that enable clinical trials. Regulatory approval for the study was obtained in late 2023 and the study was officially launched on January 5th of this year, with enrollment of the first participant in the sepsis cohort on January 8th.
The second phase of the program in Madagascar will consist of an FDA regulated early phase clinical trial evaluating the antibody product for Y. pestis. ACESO continues to work with JPEO and the product developer planning start up activities for the initiation of the clinical trial anticipated in 2025.
This project was supported by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) Joint Project Lead for Enabling Biotechnologies (JPL CBRND EB).
The views expressed in this press release reflect the views of the authors and do not necessarily reflect the position of the Department of the Army, Department of Defense, nor the United States Government. References to non-federal entities or their products do not constitute or imply Department of Defense or Army endorsement of any company, product, or organization.
The Study protocols are IRB approved and in compliance with all applicable federal regulations governing the protection of human subjects.
About HJF: The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is a global nonprofit organization on a mission to advance military medicine. HJF's scientific, administrative, and program operations services empower investigators, clinicians, and medical researchers around the world to make discoveries in all areas of medicine. With more than 40 years of experience, HJF is the connective tissue between the military medical community, federal and private partners, and the millions of warfighters, veterans, and civilians who benefit from military medicine.