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

NCT00001123 | Completed

• 1 other identifier: 95-066
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Hantavirus Pulmonary Syndrome

Interventions

Ribavirin DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

NIAID/DMID/CASG Central Unit

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Hantavirus Pulmonary Syndrome

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Hantavirus Infections; Bunyaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 17, 2000
• First Posted: August 31, 2001
• Study Completion: November 1, 2005
• Last Updated: August 27, 2010

Record last verified: 2005-11

Locations

US (1)