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Completed

NCT Number: NCT00001123

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.

Completed

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NIAID/DMID/CASG Central Unit

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ribavirin

Drug

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Important dates

Study completion
2005
First posted
Aug 31, 2001
Registry last updated
Aug 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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