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

Tracking Information
First Received Date ^ICMJE	January 17, 2000
Last Updated Date	November 11, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001123 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Collaborative Double-Blind Placebo-Controlled Trial of Intravenous Ribavirin As a Treatment for Presumed Hantavirus Pulmonary Syndrome
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind
Condition ^ICMJE	Hantavirus Pulmonary Syndrome
Intervention ^ICMJE	Drug: Ribavirin
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	130
Completion Date	November 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00001123
Responsible Party
Study ID Numbers ^ICMJE	95-066
Study Sponsor ^ICMJE	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date	November 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP