Clinical Trial: Treatment of Viral Hemorrhagic Fevers With Intravenous Ribavirin in Military Treatment Facilities
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: Treatment of Viral Hemorrhagic Fever (Crimean-Congo Hemorrhagic Fever or Lassa Fever) With Intravenous Ribavirin in Department of Defense (DOD
Brief Summary: This is a Phase 2 study of the safety and efficacy of Intravenous (IV) Ribavirin in treating patients presenting with a probable or suspected case of viral hemorrhagic fever (either Crimean Congo or Lassa Fever) at a military medical treatment hospital. All patients will be treated with a 10 day course of IV Ribavirin if they meet all the inclusion and none of the exclusion criteria.
Detailed Summary:
Department of Defense operations have resulted in the deployment of personnel to areas endemic for Viral Hemorrhagic Fever (VHF): Crimean-Congo Hemorrhagic Fever (CCHF) or Lassa Fever. Unfortunately, beyond supportive care, there is no approved therapy for treating either infection. Previous studies with intravenous (IV) Ribavirin have shown IV Ribavirin as a promising treatment for both infections. This study will provide experience in U.S. Department of Defense associated treatment facilities in the use of IV Ribavirin for the experimental treatment of viral hemorrhagic fevers primarily among U.S. Service personnel deployed to disease-endemic areas.
The rationale for conducting the study is a) to allow the DoD to gain experience in treating VHF b) to offer this experimental but promising therapy to patients with probable or suspected VHF c) to collect safety data while obtaining experience using Ribavirin.
Sponsor: U.S. Army Medical Research and Materiel Command
Current Primary Outcome:
- Number of adverse events [ Time Frame: 5 years ]
- Number of deaths of individuals with viral hemorrhagic fever (Crimean-Congo hemorrhagic fever or Lassa fever) who received at least four doses of IV Ribavirin [ Time Frame: 5 years ]
Original Primary Outcome: To evaluate the safety of IV Ribavirin in subjects with a probable case of viral hemorrhagic fever (VHF) and to monitor the mortality of subjects with VHF who are treated with Ribavirin. [ Time Frame: As needed or every 5 years ]
Current Secondary Outcome: Number of clinical events [ Time Frame: 5 years ]
Original Secondary Outcome: To evaluate IV Ribavirin drug intervention on clinical events that occur with VHF. [ Time Frame: As needed or every 5 years ]
Information By: U.S. Army Medical Research and Materiel Command
Dates:
Date Received: October 8, 2009
Date Started: September 2009
Date Completion: January 2018
Last Updated: May 2, 2017
Last Verified: May 2017
