Respiratory Syncytial Virus - RSV Protocol
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.
Bone Marrow Transplant Infection
Infection in Marrow Transplant Recipients
Respiratory Syncytial Virus Infections
Respiratory Syncytial Virus Pneumonia
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Number of Participants with Progression to Lower Respiratory Tract Infection (LRI) [ Time Frame: 14 days ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2011|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Inhaled Ribavirin
Group 1: Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.
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.
Experimental: Oral Ribavirin
Group 2: Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.
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).
No Intervention: No Ribavirin
Group 3: No Ribavirin treatment.
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|Contact: Roy F. Chemaly, MD||713-792-0007|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Study Chair:||Roy F. Chemaly, MD||UT MD Anderson Cancer Center|