A Randomized Study Evaluating Two Different Schedules of Aerosolized Ribavirin For Treatment of RSV Upper Respiratory Infections in Patients With Hematological Malignancies
5 Years
N/A
Both
Hematological Malignancies
Trial Information
A Randomized Study Evaluating Two Different Schedules of Aerosolized Ribavirin For Treatment of RSV Upper Respiratory Infections in Patients With Hematological Malignancies
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 washings/swabs. 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 and/or 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.
Inclusion Criteria:
1. Patients with these underlying malignancies will be eligible for this study:
Autologous BMT patients, Allogeneic BMT patients, and patients with hematological
malignancy.
2. Patients must be at least 5 years of age.
3. Only patients with infection limited to the URT will be eligible for entry on study
4. Patients will be eligible for entry on study if a nasopharyngeal wash or throat swab
specimen is positive by rapid RSV antigen testing or by a positive culture for RSV.
Exclusion Criteria:
1. Patients with evidence of RSV LRTI as documented by a positive rapid RSV antigen
testing or by a positive culture for RSV from a nasopharyngeal wash or throat swab
AND new infiltrates on chest radiograph and/or abnormal blood gas determination
2. Patients with hypersensitivity to ribavirin or its components
3. Pregnant women. Participants must practice birth control during the study if they are
sexually active. If the participant is pregnant, she may not be enrolled on this
study. Mothers should refrain from breast-feeding during the study to avoid injury to
their children.
4. Patients with positive RSV by rapid testing or culture in bronchoalveolar lavage
regardless of the chest radiographic results.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Occurrences of Pneumonia
Outcome Description:
Treatment failure defined as progression to pneumonia within 7 days of initial treatment with aerosolized ribavirin. Patients considered as a failure or to have an unfavorable response if there develop signs and symptoms of pneumonia during therapy either evidenced by chest-xray or clinically, meaning they did reach the primary endpoint.
Outcome Time Frame:
6 Years
Safety Issue:
No
Principal Investigator
Roy F. Chemaly, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
ID03-0010
NCT ID:
NCT00500578
Start Date:
February 2003
Completion Date:
January 2009
Related Keywords:
- Hematological Malignancies
- Hematological Malignancies
- Respiratory Infection
- Respiratory Syncytial Virus
- RSV
- Ribavirin
- Virazole
- Neoplasms
- Respiratory Tract Infections
- Hematologic Neoplasms
Name | Location |
|---|---|
| U.T.M.D. Anderson Cancer Center | Houston, Texas 77030 |
