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| Sponsor: | U.S. Army Medical Research and Materiel Command |
|---|---|
| Information provided by: | U.S. Army Medical Research and Materiel Command |
| ClinicalTrials.gov Identifier: | NCT00992693 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Crimean-Congo Hemorrhagic Fever Lassa Fever |
Drug: Ribavirin (Virazole) Injection manufactured for Valeant Pharmaceuticals North America |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 manufactured for Valeant Pharmaceuticals North America
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
|
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.
Eligibility| Ages Eligible for Study: | 17 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
An individual will be enrolled in this study if the patient:
Note: Malaria should be excluded as a possibility for illness in patients suspected to have VHF.
Probable Case of Crimean-Congo Hemorrhagic Fever:
All subjects will have a history of possible exposure to CCHF, either having:
Worked with the virus in the laboratory setting and have a clinical syndrome consistent with CCHF as defined by:
And the appearance of three or more of the following five groups of signs/symptoms:
Prognostic indicators exist for subjects at increased risk of severe CCHF. Any of these indicators occurring in the first 5 days of illness, predict a mortality greater than 90% (Swanepoel et al., 1989). Patients with these prognostic indicators may benefit most from drug therapy, if resources become limiting:
Probable Case of Lassa Fever:
All subjects will have a history of possible exposure to Lassa fever, either having:
Signs and symptoms compatible with Lassa fever, either:
Exclusion Criteria:
Relative Exclusion Criteria:
At the principal investigator's (PI) discretion, an individual may be treated with IV Ribavirin, with caution, if one of these criteria is present:
Use of drugs known to result in bradyarrhythmias (certain betablockers and calcium channel blockers, digoxin).
f. History of gout or tophaceous gout.
Contacts and Locations| Germany | |
| Landstuhl Regional Medical Center | |
| Landstuhl, Rheinland-Pfalz, Germany | |
| Principal Investigator: | Nicholas Conger, MD | Landstuhl Regional Medical Center, Germany |
More Information
| Responsible Party: | Robert E. Miller, Ph.D. RAC, Sponsor's Representative, USAMMDA |
| ClinicalTrials.gov Identifier: | NCT00992693 History of Changes |
| Other Study ID Numbers: | C2009.140 |
| Study First Received: | October 8, 2009 |
| Last Updated: | May 11, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Crimean-Congo Hemorrhagic Fever Lassa Fever CCHF LF |
Viral Hemorrhagic Fever VHF Ribavirin |
|
Fever Hemorrhagic Fever, Crimean Hemorrhagic Fevers, Viral Lassa Fever Body Temperature Changes Signs and Symptoms Tick-Borne Diseases Arbovirus Infections Virus Diseases Bunyaviridae Infections |
RNA Virus Infections Arenaviridae Infections Ribavirin Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action |