InfectionPhase 3NCT00016081
Ribavirin Compared With Standard Care in Treating Patients With Respiratory Syncytial Virus Following Stem Cell Transplantation
A Phase 3 study testing ribavirin in people with Infection, run by Fred Hutchinson Cancer Center at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Infection
- What is being tested?
- ribavirin
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- Mar 1998to 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35233
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
Siteman Cancer Center
St Louis, Missouri, 63110
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ribavirinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 1998
- Primary completionMar 2003
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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
- Supportive care
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Michael Boeckh, MD, Study chair, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016081
- Sponsor's protocol ID
- 1290.00
- Other IDs
- FHCRC-1290.00, NCI-G01-1939, CDR0000068593
- Status last verified
- Mar 2010
- First submitted
- 6 May 2001
- Last updated
- 30 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 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 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
- ClinicalTrials.gov ID
- NCT00016081
- Acronym / sponsor ID
- 1290.00
- Conditions
- Infection
- Keywords
- infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 1998
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 27 Jan 2003 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| ribavirin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 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.
Michael Boeckh, MD study chair
Fred Hutchinson Cancer Center
4 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 ribavirin in people with Infection, run by Fred Hutchinson Cancer Center at 4 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?
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: finished, as of the sponsor's last update on 30 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 30 Mar 2010.