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

This study has been completed.

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00001123

Purpose

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	Intervention
Hantavirus Pulmonary Syndrome	Drug: Ribavirin

Drug Information available for: Ribavirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind
Official Title:	A Collaborative Double-Blind Placebo-Controlled Trial of Intravenous Ribavirin As a Treatment for Presumed Hantavirus Pulmonary Syndrome

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:	130
Estimated Study Completion Date:	November 2005

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.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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)

More Information

Study ID Numbers:	95-066
Study First Received:	January 17, 2000
Last Updated:	November 11, 2005
ClinicalTrials.gov Identifier:	NCT00001123
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Virus Diseases
Respiratory Insufficiency
Hantavirus pulmonary syndrome
Respiratory Tract Diseases

Ribavirin
Respiration Disorders
Hantavirus Pulmonary Syndrome
Hantavirus Infections

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Bunyaviridae Infections
Pathologic Processes
Disease

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Syndrome
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009