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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   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)
First Received: January 17, 2000   Last Updated: November 11, 2005   History of Changes

January 17, 2000
November 11, 2005
 
 
 
 
Complete list of historical versions of study NCT00001123 on ClinicalTrials.gov Archive Site
 
 
 
A Collaborative Double-Blind Placebo-Controlled Trial of Intravenous Ribavirin As a Treatment for Presumed Hantavirus Pulmonary Syndrome
A Collaborative Double-Blind Placebo-Controlled Trial of Intravenous Ribavirin As a Treatment for Presumed Hantavirus Pulmonary Syndrome

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.

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.

 
Interventional
Treatment, Double-Blind
Hantavirus Pulmonary Syndrome
Drug: Ribavirin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
130
November 2005
 

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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001123
 
95-066
National Institute of Allergy and Infectious Diseases (NIAID)
 
 
National Institute of Allergy and Infectious Diseases (NIAID)
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP