Clinical Trial: Ribavirin for Hemorrhagic Fever With Renal Syndrome in Germany
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: A Phase 2 Treatment Protocol of Intravenous Ribavirin in Adult Subjects With Hemorrhagic Fever With Renal Syndrome (HFRS) in Landstuhl Regional Medical Center (Landstuhl,
Brief Summary: This is a treatment protocol using IND Ribavirin-there is no control group. Hemorrhagic Fever with Renal Syndrome (HFRS) is caused by a virus acquired by contact with chronically infected rodent hosts. HFRS is present throughout Europe and caused mainly by Puumala and Dobrava viruses. 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 (determination if the disease is caused by Puumala or Dobrava virus is helpful) 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:
This is a Phase 2, open label study of the safety of IV Ribavirin treatment in individuals with HFRS admitted to the Landstuhl Regional Medical Center, Germany. The study will also monitor the morbidity and mortality of subjects with HFRS who are treated with IV Ribavirin. The study population will include all subjects with a probable or suspected clinical diagnosis of HFRS and meet entry criteria with a 7 day course of IV Ribavirin and a 28-60 day follow up period after the first dose of Ribavirin. In addition to treatment with Ribavirin, all subjects will be given standard supportive and symptomatic care as determined by the clinical judgment of the Principal Investigator, attending physicians or consultants who manage the subject's care at LRMC. Up to 50 subjects could potentially be enrolled in a five year time period with an expected accrual of 0-5 subjects per year. Specific inclusion/exclusion/relative exclusion criteria are a part of the protocol. Safety procedures required during 7 days of treatment include continuous cardiac monitoring, daily lab work, physical exams and vital signs.
Hemorrhagic fever with renal syndrome (HFRS) is caused by viruses in the genus Hantavirus of the family Bunyaviridae. There are four known Hantaviruses that cause HFRS: Hantaan, Seoul, Puumala, and Dobrava viruses. Hantaan virus is a spherical, enveloped virus and has been designated the prototype for the Hantavirus genus family Bunyaviridae (Schmaljohn, 1983). Serologic, morphologic, and biochemical studies have established that this virus is related to Puumala virus, Seoul virus, and other Hantaviruses (Schmaljohn, 1985). HFRS is acquired by contact with chronically infected rodent hosts, most commonly from inhalation of infected rodent excreta (urine, saliva, and feces) but also reported from rodent bites. In Europe, HFRS is caused mainly by Puumala and Dobrava viruses, with Puum
Sponsor: U.S. Army Medical Research and Materiel Command
Current Primary Outcome:
- Number of subject who develop oliguria [ Time Frame: 5 years ]Number of subject who develop oliguria (≤ 400 mL of urine in a 24-hour period), who require hemodialysis, who have cardiac arrhythmias, or who experience severe hemorrhage [results in hypotension (< 90 mm Hg systolic blood pressure) or hemorrhagic shock]. Subject mortality will be evaluated.
- Number of mortalities [ Time Frame: 5 years ]
Original Primary Outcome: To monitor the morbidity (clinical events that occur with HFRS including oliguria, dialysis requirement, cardiac arrhythmias, and severe hemorrhage) and mortality of the subjects with HFRS who are treated with IV Ribavirin. [ Time Frame: 5 years ]
Current Secondary Outcome: Number and type of adverse events for all subjects. [ Time Frame: 5 years ]
Original Secondary Outcome: To evaluate the safety of IV Ribavirin treatment in subjects with a probable or suspected case of hemorrhagic fever with renal syndrome (HFRS). [ Time Frame: 5 years ]
Information By: U.S. Army Medical Research and Materiel Command
Dates:
Date Received: March 24, 2009
Date Started: October 2009
Date Completion:
Last Updated: October 11, 2016
Last Verified: August 2016
