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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00001123
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : August 27, 2010
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment
Hantavirus Pulmonary Syndrome Drug: Ribavirin

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Masking: Double
Primary Purpose: Treatment
Official Title: A Collaborative Double-Blind Placebo-Controlled Trial of Intravenous Ribavirin As a Treatment for Presumed Hantavirus Pulmonary Syndrome
Estimated Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001123


Locations
United States, Alabama
NIAID/DMID/CASG Central Unit
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier: NCT00001123     History of Changes
Obsolete Identifiers: NCT00004267
Other Study ID Numbers: 95-066
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: November 2005

Additional relevant MeSH terms:
Syndrome
Hantavirus Pulmonary Syndrome
Hantavirus Infections
Disease
Pathologic Processes
Bunyaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents