Trial record 3 of 7 for:    hantavirus

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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001123
First received: January 17, 2000
Last updated: August 26, 2010
Last verified: November 2005
  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

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00001123     History of Changes
Obsolete Identifiers: NCT00004267
Other Study ID Numbers: 95-066
Study First Received: January 17, 2000
Last Updated: August 26, 2010
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 30, 2014