- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00016081
Ribavirin Compared With Standard Care in Treating Patients With Respiratory Syncytial Virus Following Stem Cell Transplantation
A Randomized Phase III Study To Evaluate The Safety And Efficacy Or Ribavirin Inhaled Solution In Preventing Progression Of Upper Respiratory Tract Respiratory Syncytial Virus (RSV) Infection To RSV Pneumonia In Blood And Bone Marrow Transplant (BMT) Recipients
RATIONALE: Antivirals such as ribavirin are used to treat infections caused by viruses. It is not yet known if ribavirin is more effective than standard therapy in preventing pneumonia in patients who have respiratory syncytial virus (RSV) infection following stem cell transplantation.
PURPOSE: Randomized phase III trial to compare the effectiveness of ribavirin with that of standard therapy in preventing pneumonia in patients who have RSV infection following stem cell transplantation.
Study Overview
Detailed Description
OBJECTIVES:
- Compare the efficacy of aerosolized ribavirin vs standard supportive therapy, in terms of preventing progression of upper respiratory tract respiratory syncytial virus (RSV) infection to pneumonia, in patients with RSV following stem cell transplantation.
- Determine the safety of aerosolized ribavirin in this patient population.
OUTLINE: This is a randomized, investigator-blind, controlled, multicenter study. Patients are stratified according to engraftment status (pre vs post) and transplant type (HLA matched-related allogeneic, syngeneic, or autologous vs HLA mismatched-related or unrelated allogeneic). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive standard supportive care for immunocompromised patients with upper respiratory tract infections. Patient also receive aerosolized ribavirin by face mask, mist, or oxygen tent over 2 hours 3 times daily on days 1-10.
- Arm II: Patients receive standard supportive care as in arm I. Treatment continues in the absence of progression to pneumonia or unacceptable toxicity.
Patients are followed at days 14 and 28.
PROJECTED ACCRUAL: A total of 90 patients (45 per arm) will be accrued for this study.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham Comprehensive Cancer Center
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-
Illinois
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Chicago, Illinois, United States, 60637-1470
- University of Chicago Cancer Research Center
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Missouri
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Saint Louis, Missouri, United States, 63110
- Siteman Cancer Center
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Washington
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Seattle, Washington, United States, 98109-1024
- Fred Hutchinson Cancer Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Confirmed upper respiratory tract respiratory syncytial virus (RSV) infection documented in nasopharyngeal-throat specimen by rapid antigen test (ELISA), IFA, or shell vial)
- Signs or symptoms of upper respiratory tract infection (e.g., rhinorrhea and/or low-grade fever (under 101 degrees F with or without evidence of a sore throat)
Received prior stem cell transplantation (SCT) and meet one of the following criteria:
- Between start of conditioning (preparative) regimen and day 90 after allogeneic, autologous, or syngeneic SCT
- Between days 91 and 180 after unrelated or HLA mismatch-related allogeneic SCT
- Between days 91 and 180 after SCT with graft-versus-host disease requiring systemic steroids expected to continue throughout study
- No radiographic evidence of pneumonia
PATIENT CHARACTERISTICS:
Age:
- 2 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Pulmonary:
- Oxygen saturation 92-100% by pulse oximeter
- Normal respiratory rate for age
Other:
- No prior adverse reactions to ribavirin
- No clinical status that would preclude study
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- No prior immunotherapy for RSV
- No prior or concurrent RSV hyperimmune globulin or monoclonal antibodies
Chemotherapy:
- Not specified
Endocrine therapy:
- See Disease Characteristics
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No prior antiviral drugs with anti-RSV activity
- Bronchodilator treatment allowed for patients with asthma or a history of reactive airway disease and/or who develop bronchospasm
- Concurrent ganciclovir, foscarnet, or IV immunoglobulin allowed
- No mechanical ventilation
- No other concurrent anti-viral drugs with anti-RSV activity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Michael Boeckh, MD, Fred Hutchinson Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1290.00
- FHCRC-1290.00
- NCI-G01-1939
- CDR0000068593 (Registry Identifier: PDQ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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