Completed

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

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What is being tested

Ribavirin

Drug
Who is being recruted

Bunyaviridae Infections+6

+ Infections

+ Respiration Disorders

Over 12 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: August 27, 2010
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: August 27, 2010
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

130 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bunyaviridae InfectionsInfectionsRespiration DisordersRespiratory InsufficiencyRespiratory Tract DiseasesRNA Virus InfectionsVirus DiseasesHantavirus InfectionsHantavirus Pulmonary Syndrome

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

NIAID/DMID/CASG Central Unit

Birmingham, United StatesOpen NIAID/DMID/CASG Central Unit in Google Maps
CompletedOne Study Center