A Collaborative Double-Blind Placebo-Controlled Trial of Intravenous Ribavirin As a Treatment for Presumed Hantavirus Pulmonary Syndrome - Tabular View

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A Collaborative Double-Blind Placebo-Controlled Trial of Intravenous Ribavirin As a Treatment for Presumed Hantavirus Pulmonary Syndrome

This study has been completed.

Study NCT00001123. Last updated on November 11, 2005. Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	A Collaborative Double-Blind Placebo-Controlled Trial of Intravenous Ribavirin As a Treatment for Presumed Hantavirus Pulmonary Syndrome
Official Title ^†	A Collaborative Double-Blind Placebo-Controlled Trial of Intravenous Ribavirin As a Treatment for Presumed Hantavirus Pulmonary Syndrome
Brief Summary	The purpose is to test the safety and effectiveness of intravenous ribavirin therapy in persons with suspected and subsequently proven hantavirus infection. The hantavirus is spread through the air into the lungs when dry rodent feces are moved or disturbed. It is characterized by fever and bleeding.
Detailed Description	Patients are randomized to receive either ribavirin or a placebo for 7 days. At the completion of therapy, patients will be seen on follow-up visits on days 14, 28, and 84.
Study Phase
Study Type ^†	Interventional
Study Design ^†	Treatment, Double-Blind
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Hantavirus Pulmonary Syndrome
Intervention ^†	Drug: Ribavirin
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	130
Start Date ^†
Completion Date	November 2005
Eligibility Criteria ^†	Inclusion Criteria: You may be eligible for this study if you: Are 12 years of age or older. Are not pregnant. Agree to practice sexual abstinence or use accepted barrier methods of birth control/contraception. Are not breast-feeding. Have a positive blood test for hantavirus. Have symptoms suggestive of hantavirus illness. Exclusion Criteria: You will not be eligible for this study if you: Have severe low blood count (anemia). Have a diagnosis of other respiratory viruses (influenza, RSV, etc.). Have group A Streptococcus with symptoms of streptococcal pharyngitis, a positive culture from a normally sterile site, or symptoms of bacterial pneumonia. Are HIV positive. Have cancer. Have had any period of irregular heartbeat. Have had chemotherapy or other drugs that suppress the immune system within 30 days. Have taken by mouth or injection any antiviral drug (other than acyclovir, famciclovir, amantadine or rimantadine.) Have taken by mouth or injection corticosteroids equivalent to approximately 0.5 mg/kg prednisone. Have taken any experimental drug within 30 days prior to enrollment.
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00001123
Organization ID	95-066
Secondary IDs ^††
Study Sponsor ^†	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ^††
Investigators ^†
Information Provided By	National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date	November 2005
First Received Date ^†	January 17, 2000
Last Updated Date	November 11, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.