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Safety and Tolerability of Adding Dexamethasone to Standard Ribavirin Treatment for Moderate to Severe Lassa Fever in Adults
Led by Bernhard Nocht Institute for Tropical Medicine · Updated on 2025-02-06
42
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Lassa fever is a serious and often deadly disease caused by the Lassa virus, mainly affecting people in West Africa. This research aims to evaluate the safety and side effects of adding dexamethasone, a corticosteroid that may reduce harmful inflammation, to the standard antiviral treatment ribavirin for moderate to severe cases of Lassa fever. The study is a phase II, open-label, randomized clinical trial designed to understand how dexamethasone influences disease progression and immune responses. Participants will be randomly assigned to one of two groups one receiving ribavirin alone and the other receiving ribavirin combined with dexamethasone. Dexamethasone will be given intravenously for the first 48 hours, then possibly switched to oral form for the remaining 8 days. Ribavirin treatment will be administered intravenously for 10 days according to national guidelines. The trial will last at least 10 days after enrollment for each participant. During the study, participants will be closely monitored for adverse effects and changes in their health status, including blood tests to measure liver and kidney function, immune markers, and viral load. Researchers will also study how dexamethasone is processed in the body. Follow-up assessments will continue until 10 days after enrollment to evaluate safety, disease outcomes, and biological responses. The overall goal is to better understand the potential role of dexamethasone as an additional treatment for Lassa fever.
CONDITIONS
Brief Title
LAssa Fever Adjunct Treatment With DEXamethasone
Research Team
M
Mirjam Groger, Dr.
S
Stephan Günther, Prof.
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