Bone Marrow Transplant InfectionPhase 2NCT01502072
Respiratory Syncytial Virus - RSV Protocol
A Phase 2 study testing Ribavirin in people with Bone Marrow Transplant Infection and Infection in Marrow Transplant Recipients, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if ribavirin can help to control RSV in patients with immune systems that have been weakened by a stem cell transplant. Researchers also want to compare the effectiveness of the drug when it is given by mouth to when it is inhaled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Marrow Transplant Infection, Infection in Marrow Transplant Recipients, Respiratory Syncytial Virus Infections
- What is being tested?
- Ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2011to 1 Feb 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HSCT patients with either moderate or severe immunodeficiency based on immunodeficiency scoring system would be eligible for entry on study if a nasopharyngeal wash or throat swab specimen is positive by rapid RSV antigen testing and/or on culture within 72 hours (therapeutic arms). (Please see Appendix E for definitions and Immunodeficiency Scoring).
- HSCT patients with mild immunodeficiency based on immunodeficiency scoring system would be eligible for entry on study if a nasopharyngeal wash or throat swab specimen is positive by rapid RSV antigen testing and/or on culture within 72 hours but will not be randomized to therapeutic arms and will be followed as per standard of care (control arm).
- Patients must be at least 18 years of age and able to swallow pills.
- Patients with RSV infection limited to the URT as documented by negative Chest radiographic findings within the last 48 hours of enrollment and pulse oxygenation of more than 90 mm of Hg on room air.
- Women of child bearing potential with a negative urine or blood pregnancy test within a month of enrollment (only for patients who are going to be randomised to either therapeutic arms).
- Patients with Hemoglobin levels more than or equal to 8 g/dl would be eligible for the study even if they are currently receiving blood products.
- Patients may receive up to 2 doses of aerosolized ribavirin (modified regimen) before enrollment into the study.
- Patients who will be enrolled on the observational arm should meet inclusion criteria # 2, 3, and 4 only.
Who cannot join
- Patients with previous history of hypersensitivity to ribavirin or its components
- Women who are pregnant or plan a pregnancy within 8 weeks after completion of treatment (only for patients who are going to be randomised to either therapeutic arms).
- Patients with evidence of RSV LRI as documented by a positive rapid RSV antigen testing and/or culture on nasal washes AND new or progressive infiltrates on chest radiographic studies suggestive of viral etiology and/or pulse oxygen less than 90 mm of Hg on room air.
- Patients with positive RSV by rapid antigen testing and/or culture in bronchoalveolar lavage regardless of the chest radiographic findings.
- Patients who are considered to be moderately or severely anemic as per the NCI classification will not be included in the study, i.e patients with hemoglobin level less than 8 g/dl
- Patient with Total Bilirubin and Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) three times the upper limit of normal.
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- Male partners of women who are pregnant (only for patients who are going to be randomised to either therapeutic arms).
- Patients with known history of autoimmune hepatitis, Hepatitic C or those with hemoglobinopathies (eg, thalassemia major, sickle cell anemia).
- Patients with creatinine clearance of less than or equal to 50 ml/Min
- Patients taking didanosine, azathioprine, or nucleoside reverse transcriptase inhibitors
- Patients who will be enrolled on the observational arm should not meet exclusion criteria #3 and 4 only.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: An Open Label Randomized Controlled Trial To Prevent the Progression of Respiratory Syncytial Virus Upper Respiratory Tract Infection to Lower Respiratory Tract Infection in Patients After Hematopoietic Stem Cell Transplant
The goal of this clinical research study is to learn if ribavirin can help to control RSV in patients with immune systems that have been weakened by a stem cell transplant. Researchers also want to compare the effectiveness of the drug when it is given by mouth to when it is inhaled. The safety of the drug in both methods of delivery will be studied.
Ribavirin is designed to prevent the RSV virus from making more copies of itself in the body.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study and the study doctor thinks that the disease requires treatment at this time, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group:
- If you are in Group 1, you will receive the inhaled form of ribavirin. You will inhale ribavirin 3 times a day for 3 hours each time in a tent in a hospital room. You will receive the drug for up to 10 days.
- If you are in Group 2, you will take capsules of ribavirin 3 times a day for up to 10 days.
If the study doctor does not think that the disease requires treatment at this time, you will be assigned to Group 3. If you are in Group 3, you will not receive treatment with ribavirin, but you will have the same tests and procedures at the study visits described below.
Study Visits:
At all study visits, you will be asked about how you are feeling, about any side effects or symptoms you may be having, and about any other drugs you may be taking.
On Day 3 (+/- 1 day):
- You will have a physical exam, including measurement of your vital signs
- Your nasal passages will be checked for RSV.
On Days 7 and 14 (+/- 1 day):
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will have a physical exam, including measurement of your vital signs
- Your nasal passages will be checked for RSV.
Length of Study:
If you are in Groups 1 or 2, you will receive the study drug for up to 10 days. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. If your doctor thinks you need treatment longer than 10 days, you will receive that as part of your routine care. This may mean changing to receiving the drug in inhaled form if you began the study receiving it by mouth.
All participants will have end-of-study and follow-up visits, as described below.
End-of-Study Visit:
If you are in Groups 1 or 2, the end-of-study visit will be about 14 days after your last dose of the study drug. If you are in Group 3, the end-of-study visit will take place at about Day 21. The following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs.
- Blood (about 4 teaspoons) will be drawn for routine tests and to check for RSV antibodies.
- Your nasal passages will be checked for RSV.
- You will be asked about how you are feeling, about any side effects or symptoms you may be having, and about any drugs you may be taking.
Follow-Up Visit:
About 6 to 10 weeks after your last dose of study drug, you will have a pulmonary function test to check your lung function.
This is an investigational study. Ribavirin is FDA approved and commercially available for the treatment of hepatitis C when given by mouth, and for severe RSV in children when inhaled. Giving the drug to adults with weak immune systems after a stem cell transplant is investigational.
Up to 96 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Bone Marrow Transplant Infection, Infection in Marrow Transplant Recipients, Respiratory Syncytial Virus Infections, Respiratory Syncytial Virus Pneumonia, Cancer, Acute Leukemia
- Being tested
- Ribavirin
- Keywords
- Ribavirin, Ribavirin Aerosol, Respiratory Syncytial Virus, RSV, upper respiratory tract infection, URI, Lower respiratory tract Infection, LRI, pneumonia, aerosolized ribavirin, HSCT, Hematopoietic stem cell transplantation, oral ribavirin therapy
- Medical subject headings
- Respiratory Syncytial Virus Infections, Neoplasms, Respiratory Tract Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibavirinDrug
Modified schedule of 60 milligrams/milliliter for 3-hour period 3 times/day for at least 5 days by aerosolization via a SPAG-2 generator via a face mask.
RibavirinDrug
One time loading dose of 10 mg/kg oral dose then 20 mg/kg orally (rounded to the nearest 200 mg dose) divided into three doses per day (max 1800 mg/day).
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Ribavirin | Experimental | Group 1: Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days. Receives: Drug: Ribavirin |
| Oral Ribavirin | Experimental | Group 2: Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days. Receives: Drug: Ribavirin |
| No Ribavirin | No intervention | Group 3: No Ribavirin treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Progression to Lower Respiratory Tract Infection (LRI)
Patient who developed signs of lower respiratory tract infection
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study start28 Dec 2011
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone Marrow Transplant InfectionStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roy F. Chemaly, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502072
- Sponsor's protocol ID
- 2011-0813
- Other IDs
- NCI-2012-00021
- Status last verified
- Jan 2021
- First submitted
- 22 Dec 2011
- Last updated
- 15 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Randomized Controlled Trial To Prevent the Progression of Respiratory Syncytial Virus Upper Respiratory Tract Infection to Lower Respiratory Tract Infection in Patients After Hematopoietic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT01502072
- Acronym / sponsor ID
- 2011-0813
- Conditions
- Bone Marrow Transplant Infection, Infection in Marrow Transplant Recipients, Respiratory Syncytial Virus Infections, Respiratory Syncytial Virus Pneumonia, Cancer, Acute Leukemia
- Keywords
- Ribavirin, Ribavirin Aerosol, Respiratory Syncytial Virus, RSV, upper respiratory tract infection, URI, Lower respiratory tract Infection, LRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 28 Dec 2011 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 30 Dec 2011 (estimated)
- Results
- Posted 15 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if ribavirin can help to control RSV in patients with immune systems that have been weakened by a stem cell transplant. Researchers also want to compare the effectiveness of the drug when it is given by mouth to when it is inhaled. The safety of the drug in both methods of delivery will be studied.
Ribavirin is designed to prevent the RSV virus from making more copies of itself in the body.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study and the study doctor thinks that the disease requires treatment at this time, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group:
- If you are in Group 1, you will receive the inhaled form of ribavirin. You will inhale ribavirin 3 times a day for 3 hours each time in a tent in a hospital room. You will receive the drug for up to 10 days.
- If you are in Group 2, you will take capsules of ribavirin 3 times a day for up to 10 days.
If the study doctor does not think that the disease requires treatment at this time, you will be assigned to Group 3. If you are in Group 3, you will not receive treatment with ribavirin, but you will have the same tests and procedures at the study visits described below.
Study Visits:
At all study visits, you will be asked about how you are feeling, about any side effects or symptoms you may be having, and about any other drugs you may be taking.
On Day 3 (+/- 1 day):
- You will have a physical exam, including measurement of your vital signs
- Your nasal passages will be checked for RSV.
On Days 7 and 14 (+/- 1 day):
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will have a physical exam, including measurement of your vital signs
- Your nasal passages will be checked for RSV.
Length of Study:
If you are in Groups 1 or 2, you will receive the study drug for up to 10 days. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. If your doctor thinks you need treatment longer than 10 days, you will receive that as part of your routine care. This may mean changing to receiving the drug in inhaled form if you began the study receiving it by mouth.
All participants will have end-of-study and follow-up visits, as described below.
End-of-Study Visit:
If you are in Groups 1 or 2, the end-of-study visit will be about 14 days after your last dose of the study drug. If you are in Group 3, the end-of-study visit will take place at about Day 21. The following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs.
- Blood (about 4 teaspoons) will be drawn for routine tests and to check for RSV antibodies.
- Your nasal passages will be checked for RSV.
- You will be asked about how you are feeling, about any side effects or symptoms you may be having, and about any drugs you may be taking.
Follow-Up Visit:
About 6 to 10 weeks after your last dose of study drug, you will have a pulmonary function test to check your lung function.
This is an investigational study. Ribavirin is FDA approved and commercially available for the treatment of hepatitis C when given by mouth, and for severe RSV in children when inhaled. Giving the drug to adults with weak immune systems after a stem cell transplant is investigational.
Up to 96 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inhaled Ribavirin | Experimental | Drug: RibavirinGroup 1: Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days. |
| Oral Ribavirin | Experimental | Drug: RibavirinGroup 2: Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days. |
| No Ribavirin | No intervention | –Group 3: No Ribavirin treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- HSCT patients with either moderate or severe immunodeficiency based on immunodeficiency scoring system would be eligible for entry on study if a nasopharyngeal wash or throat swab specimen is positive by rapid RSV antigen testing and/or on culture within 72 hours (therapeutic arms). (Please see Appendix E for definitions and Immunodeficiency Scoring).
- HSCT patients with mild immunodeficiency based on immunodeficiency scoring system would be eligible for entry on study if a nasopharyngeal wash or throat swab specimen is positive by rapid RSV antigen testing and/or on culture within 72 hours but will not be randomized to therapeutic arms and will be followed as per standard of care (control arm).
- Patients must be at least 18 years of age and able to swallow pills.
- Patients with RSV infection limited to the URT as documented by negative Chest radiographic findings within the last 48 hours of enrollment and pulse oxygenation of more than 90 mm of Hg on room air.
- Women of child bearing potential with a negative urine or blood pregnancy test within a month of enrollment (only for patients who are going to be randomised to either therapeutic arms).
Key exclusion criteria (11 listed)
- Patients with previous history of hypersensitivity to ribavirin or its components
- Women who are pregnant or plan a pregnancy within 8 weeks after completion of treatment (only for patients who are going to be randomised to either therapeutic arms).
- Patients with evidence of RSV LRI as documented by a positive rapid RSV antigen testing and/or culture on nasal washes AND new or progressive infiltrates on chest radiographic studies suggestive of viral etiology and/or pulse oxygen less than 90 mm of Hg on room air.
- Patients with positive RSV by rapid antigen testing and/or culture in bronchoalveolar lavage regardless of the chest radiographic findings.
- Patients who are considered to be moderately or severely anemic as per the NCI classification will not be included in the study, i.e patients with hemoglobin level less than 8 g/dl
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 |
|---|---|---|
| RibavirinModified schedule of 60 milligrams/milliliter for 3-hour period 3 times/day for at least 5 days by aerosolization via a SPAG-2 generator via a face mask. | Drug | Inhaled Ribavirin |
| RibavirinOne time loading dose of 10 mg/kg oral dose then 20 mg/kg orally (rounded to the nearest 200 mg dose) divided into three doses per day (max 1800 mg/day). | Drug | Oral Ribavirin |
Primary outcome
Percentage of Participants With Progression to Lower Respiratory Tract Infection (LRI)
Time frame: 14 days
Patient who developed signs of lower respiratory tract infection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Roy F. Chemaly, MD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ribavirin in people with Bone Marrow Transplant Infection and Infection in Marrow Transplant Recipients, run by M.D. Anderson Cancer Center at 1 site 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 8 inclusion and 11 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: finished, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Percentage of Participants With Progression to Lower Respiratory Tract Infection (LRI) (time frame: 14 days). It is what the study was designed to measure, not a finding.
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 15 Feb 2021.