Intermittent Use of Aerosolized Ribavirin for Treatment of RSV

This study has been completed.
Sponsor:
Collaborator:
ICN Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00500578
First received: July 10, 2007
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Hematological Malignancies
Drug: Ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Occurrences of Pneumonia [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
    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.


Enrollment: 51
Study Start Date: February 2003
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500578

Locations
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
Investigators
Principal Investigator: Roy F. Chemaly, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00500578     History of Changes
Other Study ID Numbers: ID03-0010
Study First Received: July 10, 2007
Results First Received: June 1, 2010
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Hematological Malignancies
Respiratory Infection
Respiratory Syncytial Virus
RSV
Ribavirin
Virazole

Additional relevant MeSH terms:
Neoplasms
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014