Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500578
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2007-07-10
Brief Title:
Intermittent Use of Aerosolized Ribavirin for Treatment of RSV
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Randomized Study Evaluating Two Different Schedules of Aerosolized Ribavirin For Treatment of RSV Upper Respiratory Infections in Patients With Hematological Malignancies
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objectives
1 To determine whether aerosolized ribavirin is effective when given at an intermittent dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection URI and whether it can prevent progression to pneumonia
2 To determine the effect of this regimen on persistence of viral shedding
1 To determine whether aerosolized ribavirin is effective when given at an intermittent dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection URI and whether it can prevent progression to pneumonia
2 To determine the effect of this regimen on persistence of viral shedding
Detailed Description:
Ribavirin is the drug that is normally given to treat upper respiratory infections caused by RSV The drug is only effective when inhaled as an aerosol This treatment requires the patient to be in a tent and inhale the medication The usual method for administering this drug has been to inhale the medication continuously over 18 hours In this study the same total dose of the medication will be used however treatment will be for 3 hours every 8 hours
As part of your standard care before treatment you will have blood drawn around 2 teaspoons for routine blood tests You will have a washing from your throat and nose collected For this procedure around 1 teaspoon of saline will be sprayed into each nostril and you will blow your nose into a cup You will have a swab of the nose and throat You will also have a chest x-ray to check on the status of the disease Women who are able to have children must have a negative blood or urine pregnancy test
Before treatment you will be randomly assigned as in the toss of a coin to one of two groups Participants in one group will receive treatment with ribavirin over 3 hours every 8 hours Participants in the other group will receive treatment using the standard treatment schedule ribavirin over 18 hours every 24 hours
For both groups the drug will be administered as an aerosol using a face mask This will require you to be in a tent while you are receiving therapy Treatment will last between 5 and 10 days This will require hospitalization In addition to ribavirin treatment you will also receive Xopenex inhalation therapy every 6 - 8 hours Xopenex is a drug designed to make breathing easier We may need to use another breathing treatment albuterol inhalation therapy for one time if needed directly after receiving ribavirin to make breathing easier
Every 2-4 days during treatment you will have blood collected around 2 teaspoons for routine tests On Days 3 and 7 of treatment - 2 days you will have a repeat throat and nose washingsswabs The washings and swabs will then be repeated once a week for 2 weeks or until 2 consecutive cultures are negative if that occurs sooner If your doctor feels it is necessary you may have a repeat chest x-ray
If at any time you develop signs of pneumonia you will be removed from the study and will be treated with the standard schedule of ribavirin by continuous inhalation andor other therapy for 18 hours a day Also if you develop any intolerable side effects you will be taken off the study and your doctor will discuss other treatment options with you
This is an investigational study Ribavirin is FDA approved and is commercially available However the method of administration of ribavirin is investigational Up to 50 patients will participate in this study All will be enrolled at M D Anderson
As part of your standard care before treatment you will have blood drawn around 2 teaspoons for routine blood tests You will have a washing from your throat and nose collected For this procedure around 1 teaspoon of saline will be sprayed into each nostril and you will blow your nose into a cup You will have a swab of the nose and throat You will also have a chest x-ray to check on the status of the disease Women who are able to have children must have a negative blood or urine pregnancy test
Before treatment you will be randomly assigned as in the toss of a coin to one of two groups Participants in one group will receive treatment with ribavirin over 3 hours every 8 hours Participants in the other group will receive treatment using the standard treatment schedule ribavirin over 18 hours every 24 hours
For both groups the drug will be administered as an aerosol using a face mask This will require you to be in a tent while you are receiving therapy Treatment will last between 5 and 10 days This will require hospitalization In addition to ribavirin treatment you will also receive Xopenex inhalation therapy every 6 - 8 hours Xopenex is a drug designed to make breathing easier We may need to use another breathing treatment albuterol inhalation therapy for one time if needed directly after receiving ribavirin to make breathing easier
Every 2-4 days during treatment you will have blood collected around 2 teaspoons for routine tests On Days 3 and 7 of treatment - 2 days you will have a repeat throat and nose washingsswabs The washings and swabs will then be repeated once a week for 2 weeks or until 2 consecutive cultures are negative if that occurs sooner If your doctor feels it is necessary you may have a repeat chest x-ray
If at any time you develop signs of pneumonia you will be removed from the study and will be treated with the standard schedule of ribavirin by continuous inhalation andor other therapy for 18 hours a day Also if you develop any intolerable side effects you will be taken off the study and your doctor will discuss other treatment options with you
This is an investigational study Ribavirin is FDA approved and is commercially available However the method of administration of ribavirin is investigational Up to 50 patients will participate in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None