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
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 60 days 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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants with Progression to Lower Respiratory Tract Infection (LRI)
Progression to LRI (i.e., pneumonia) by day 14 after the completion of therapy evaluated by nasal washes repeated on day 3 ±1 day, day 7 (± 2 days), day 14 (+ 2 days), and by day 14 + 2 days after end of therapy; Blood specimens drawn by 14 + 2 days after end of therapy.
14 days
No
Roy F. Chemaly, MD
Study Chair
UT MD Anderson Cancer Center
United States: Institutional Review Board
2011-0813
NCT01502072
December 2011
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |