Respiratory Syncytial Virus - RSV Protocol
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|ClinicalTrials.gov Identifier: NCT01502072|
Recruitment Status : Active, not recruiting
First Posted : December 30, 2011
Last Update Posted : September 8, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Bone Marrow Transplant Infection Infection in Marrow Transplant Recipients Respiratory Syncytial Virus Infections Respiratory Syncytial Virus Pneumonia Cancer Acute Leukemia||Drug: Ribavirin||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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.
- Number of Participants with Progression to Lower Respiratory Tract Infection (LRI) [ Time Frame: 14 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502072
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Roy F. Chemaly, MD||M.D. Anderson Cancer Center|