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Intermittent Use of Aerosolized Ribavirin for Treatment of RSV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00500578
Recruitment Status : Completed
First Posted : July 12, 2007
Results First Posted : September 16, 2010
Last Update Posted : August 1, 2012
ICN Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Hematological Malignancies Drug: Ribavirin Phase 4

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study Evaluating Two Different Schedules of Aerosolized Ribavirin For Treatment of RSV Upper Respiratory Infections in Patients With Hematological Malignancies
Study Start Date : February 2003
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Ribavirin

Arm Intervention/treatment
Experimental: 1: Standard Schedule - Ribavirin
Aerosolized Ribavirin 6 grams over 18 hours every 24 hours
Drug: Ribavirin
Arm 1 = 6 Grams Over 18 hours Every 24 Hours
Other Name: Virazole

Experimental: 2: Modified Schedule - Ribavirin
Aerosolized Ribavirin 2 grams over 3 hours every 8 hours
Drug: Ribavirin
Arm 2 = 2 Grams Over 3 Hours Every 8 Hours.
Other Name: Virazole

Primary Outcome Measures :
  1. Occurrences of Pneumonia [ Time Frame: 6 Years ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00500578

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United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
ICN Pharmaceuticals
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Principal Investigator: Roy F. Chemaly, MD M.D. Anderson Cancer Center
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00500578    
Other Study ID Numbers: ID03-0010
First Posted: July 12, 2007    Key Record Dates
Results First Posted: September 16, 2010
Last Update Posted: August 1, 2012
Last Verified: July 2012
Keywords provided by M.D. Anderson Cancer Center:
Hematological Malignancies
Respiratory Infection
Respiratory Syncytial Virus
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents