Treatment of Viral Hemorrhagic Fevers With Intravenous Ribavirin in Military Treatment Facilities
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00992693|
Recruitment Status : Enrolling by invitation
First Posted : October 9, 2009
Last Update Posted : May 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Crimean-Congo Hemorrhagic Fever Lassa Fever||Drug: Ribavirin (Virazole) Injection||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Viral Hemorrhagic Fever (Crimean-Congo Hemorrhagic Fever or Lassa Fever) With Intravenous Ribavirin in Department of Defense (DOD) Associated Medical Treatment Facilities: A Phase 2 Study|
|Actual Study Start Date :||September 2009|
|Actual Primary Completion Date :||July 19, 2016|
|Estimated Study Completion Date :||January 2019|
Experimental: Treatment with IV Ribavirin
In this open label treatment study, the investigators intend to treat all subjects who present with a tentative diagnosis of VHF and meet entry criteria with a 10 day course of IV Ribavirin.
Drug: Ribavirin (Virazole) Injection
The drug is to be administered in a volume of 50-100 ml of normal saline to be infused over 30-40 minutes.
1) Loading dose: 33 mg/kg (maximum dose 2.64 g)(1 dose) 2) Followed by a dose of 16 mg/kg (max dose 1.28 g) every 6 hours for the first 4 days (15 doses) 3) Followed by a dose of 8 mg/kg (maximum dose 0.64 g) every 8 hours for the subsequent 6 days (18 doses) Ten day course of treatment with follow up between day 28 to day 60.
Other Name: Virazole Injection, 100 mg/ml
- 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 ]
- Number of clinical events [ Time Frame: 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00992693
|Landstuhl Regional Medical Center|
|Landstuhl, Rheinland-Pfalz, Germany|
|Principal Investigator:||Elizabeth Rini, MD||Landstuhl Regional Medical Center, Germany|