Respiratory Syncytial Virus InfectionsPhase 3NCT00031473
Ribavirin to Prevent RSV Pneumonia in Bone Marrow Transplant Patients
A Phase 3 study testing Virazole (Ribavirin) Inhalation Solution in people with Respiratory Syncytial Virus Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in United States.
Trial summary
The purpose of this study is to test the safety and effectiveness of ribavirin, administered as an aerosol, in preventing progression of upper respiratory tract RSV infection to RSV pneumonia in bone marrow and peripheral blood transplant recipients. Read more about this study
- Who is it for?
- Ages 5 to 60 years
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- Virazole (Ribavirin) Inhalation Solution
- How many people
- 90 participants
- Where
- 11 sitesUnited States
- Study dates
- Nov 1997to Mar 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 2 years of age or older.
- Are not pregnant or breast-feeding and agree to use a reliable birth control method for the duration of the study.
- Are a blood or bone marrow transplant recipient.
- Have evidence of upper respiratory tract infection.
- Have nasopharyngeal-throat samples positive for RSV.
Who cannot join
- Are known to be HIV positive.
- Have pneumonia.
- Require a ventilator to breathe.
- Are pregnant.
- Are breast-feeding and are unwilling to stop breast-feeding.
- Are receiving treatment with certain other drugs for RSV.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Maryland
Baltimore, Maryland, 21201
University of Alabama at Birmingham (CASG)
Birmingham, Alabama, 35294
University of Chicago
Chicago, Illinois, 60637
City of Hope National Medical Center
Duarte, California, 91010
University of Florida
Gainesville, Florida, 32610
J. Whitcomb Riley Hosp for Chldrn - Indianapolis
Indianapolis, Indiana, 46202
St. Luke's Hospital (Kansas City, MO)
Kansas City, Missouri, 64134
University of Minnesota
Minneapolis, Minnesota, 55455
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of California, San Francisco
San Francisco, California, 94143
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: A Randomized Phase III Study to Evaluate the Safety and Efficacy of Ribavirin Inhaled Solution in Preventing Progression of Upper Respiratory Tract Respiratory Syncytial Virus Infection to RSV Pneumonia in Blood and Bone Marrow Transplant (BMT) Recipient
The purpose of this study is to test the safety and effectiveness of ribavirin, administered as an aerosol, in preventing progression of upper respiratory tract RSV infection to RSV pneumonia in bone marrow and peripheral blood transplant recipients.
Read the detailed description
The study enrolls 90 transplant recipients with positive nasal/throat culture specimens for Respiratory Syncytial Virus (RSV) infection. Patients are randomized into one of two groups: investigational treatment or standard treatment.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- Virazole (Ribavirin) Inhalation Solution
- Keywords
- Ribavirin, RSV
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virazole (Ribavirin) Inhalation SolutionDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2002 (estimated)
- Study startNov 1997
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 90 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031473
- Sponsor's protocol ID
- 97-038
- Status last verified
- Dec 2003
- First submitted
- 6 Mar 2002
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study to Evaluate the Safety and Efficacy of Ribavirin Inhaled Solution in Preventing Progression of Upper Respiratory Tract Respiratory Syncytial Virus Infection to RSV Pneumonia in Blood and Bone Marrow Transplant (BMT) Recipient
- ClinicalTrials.gov ID
- NCT00031473
- Acronym / sponsor ID
- 97-038
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Ribavirin, RSV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 90 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Nov 1997
- Study completion
- Mar 2003
- First posted
- 7 Mar 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the safety and effectiveness of ribavirin, administered as an aerosol, in preventing progression of upper respiratory tract RSV infection to RSV pneumonia in bone marrow and peripheral blood transplant recipients.
Detailed description
The study enrolls 90 transplant recipients with positive nasal/throat culture specimens for Respiratory Syncytial Virus (RSV) infection. Patients are randomized into one of two groups: investigational treatment or standard treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 2 years of age or older.
- Are not pregnant or breast-feeding and agree to use a reliable birth control method for the duration of the study.
- Are a blood or bone marrow transplant recipient.
- Have evidence of upper respiratory tract infection.
- Have nasopharyngeal-throat samples positive for RSV.
Key exclusion criteria (6 listed)
- Are known to be HIV positive.
- Have pneumonia.
- Require a ventilator to breathe.
- Are pregnant.
- Are breast-feeding and are unwilling to stop breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virazole (Ribavirin) Inhalation Solution | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Virazole (Ribavirin) Inhalation Solution in people with Respiratory Syncytial Virus Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2010.