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.

Study Overview

• Status: Completed
• Conditions: Hantavirus Pulmonary Syndrome
• Intervention / Treatment: 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
• Enrollment: 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • NIAID/DMID/CASG Central Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: Double

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

Study Major Dates

• Study Completion: November 1, 2005

Study Registration Dates

• First Submitted: January 17, 2000
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): August 27, 2010
• Last Update Submitted That Met QC Criteria: August 26, 2010
• Last Verified: November 1, 2005

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Respiration Disorders; Disease; Respiratory Insufficiency; Bunyaviridae Infections; Syndrome; Hantavirus Pulmonary Syndrome; Hantavirus Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Ribavirin
• Other Study ID Numbers: 95-066