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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)

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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
Links
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.




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