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

Hantavirus Pulmonary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001123
• Other study ID #: 95-066
• Status: Completed
• Phase: N/A
• First received: January 17, 2000
• Last updated: August 26, 2010
• Est. completion date: November 2005

Study information

• Verified date: November 2005
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00004267

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hantavirus Pulmonary Syndrome
• Syndrome

Intervention

Drug:
• Ribavirin

Locations

Country	Name	City	State
United States	NIAID/DMID/CASG Central Unit	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States,