Clinical Trial: Ribavirin for Hemorrhagic Fever With Renal Syndrome
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: A Phase 2 Treatment Protocol of Intravenous Ribavirin in Adult Subjects With Hemorrhagic Fever With Renal Syndrome (HFRS) in the 121st Combat Support Hospital (Seoul, Kore
Brief Summary: Hemorrhagic Fever with Renal Syndrome (HFRS) is caused by a virus acquired by contact with chronically infected rodent hosts. HFRS is present throughout Korea. Treatment consists mainly of supportive care with careful attention to control of blood pressure and fluid balance and/or dialysis. Early initiation of IND Intravenous Ribavirin has been shown to be an effective treatment for HFRS and may prevent the need for dialysis. It is important to initiate therapy based on a diagnosis consistent with HFRS and a history that makes exposure likely. This study will monitor the clinical events that occur with HFRS as well as the safety and efficacy of Ribavirin.
Detailed Summary:
Hemorrhagic Fever with Renal Syndrome (HFRS) is caused by viruses in the genus Hantavirus of the family Bunyaviridae. There are four known Hantavirus that cause HFRS: Hantaan, Seoul, Puumala and Dobrava viruses. HFRS is acquired by contact with chronically infected rodent hosts, most commonly from inhalation of infected rodent excreta. Hemorrhagic fever with renal syndrome is characterized clinically by the triad of fever, hemorrhage and renal insufficiency. HFRS typically consists of five consecutive but frequently overlapping clinical phases: febrile, hypotensive, oliguric, diuretic and convalescent. DoD operations have resulted in the deployment of personnel in Europe and Southeast Asia, areas endemic for HFRS, a viral hemorrhagic fever. Early initiation of therapy with intravenous Ribavirin has been shown to be an effective treatment for HFRS. It is therefore important to initiate therapy based on a clinical diagnosis consistent with viral hemorrhagic fever and with an epidemiological history for risk of exposure to the hantavirus. Ribavirin is a nucleoside (guanosine) analog with activity against a wide variety ribonucleic acid and deoxyribonucleic acid viruses. Mechanism of action is not fully defined. The mechanism may be related to alteration of cellular nucleotide pools and of viral messenger RNA formation, but recent data suggest the mechanism of Ribavirin in HFRS may be to serve as a RNA virus mutagen resulting in an "extinction catastrophe" error, as a result of incorporation in the viral RNA genome.
Ribavirin is licensed in the United States in aerosol form for the treatment of severe lower respiratory tract infection in children and in the oral formulation in combination with recombinant interferon alpha for the treatment of chronic hepatitis C infection. The intravenous formulation of ribavirin in not licensed in the United States. IV Ribavirin fo
Sponsor: U.S. Army Medical Research and Materiel Command
Current Primary Outcome:
- Number clinical events that occur with HFRS including oliguria, dialysis requirement, cardiac arrhythmias, and severe hemorrhage [ Time Frame: 5 years ]
- Number of mortalities [ Time Frame: 5 years ]
Original Primary Outcome: To monitor the morbidity and mortality of subjects with HFRS who are treated with IV Ribavirin. To evaluate the safety of IV Ribavirin treatment in subjects with a probable case of hemorrhagic fever with renal syndrome (HFRS). [ Time Frame: 5 years ]
Current Secondary Outcome: Number and nature of adverse events [ Time Frame: 5 years ]
Original Secondary Outcome: Number of subjects who develop oliguria; Number of subjects who require hemodialysis; Number of subjects with severe hemorrhage. Number subject deaths. Frequency and nature of adverse events will be evaluated for all subjects. [ Time Frame: 5 years ]
Information By: U.S. Army Medical Research and Materiel Command
Dates:
Date Received: February 13, 2008
Date Started: February 2008
Date Completion: February 2018
Last Updated: August 24, 2016
Last Verified: August 2016
