Respiratory Syncytial Virus - RSV Protocol

This study is currently recruiting participants.
Verified February 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01502072
First received: December 22, 2011
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants with Progression to Lower Respiratory Tract Infection (LRI) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 96
Study Start Date: December 2011
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inhaled Ribavirin
Group 1: Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.
Drug: Ribavirin
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.
Drug: Ribavirin
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.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HSCT patients with either moderate or risks or high risks immunodeficiency based on immunodeficiency scoring system would be eligible for entry on study if a nasopharyngeal wash or throat swab specimen is positive by rapid RSV antigen testing and/or on culture within 72 hours (therapeutic arms). (Please see Appendix E for definitions and Immunodeficiency Scoring).
  2. HSCT patients with low risk immunodeficiency based on immunodeficiency scoring system would be eligible for entry on study if a nasopharyngeal wash or throat swab specimen is positive by rapid RSV antigen testing and/or on culture within 72 hours but will not be randomized to therapeutic arms and will be followed as per standard of care (control arm).
  3. Patients must be at least 18 years of age and able to swallow pills.
  4. Patients with RSV infection limited to the URT as documented by negative Chest radiographic findings within the last 48 hours of enrollment and pulse oxygenation of more than 90 mm of Hg on room air.
  5. Women of child bearing potential with a negative urine or blood pregnancy test within a month of enrollment (only for patients who are going to be randomised to either therapeutic arms).
  6. Patients with Hemoglobin levels more than or equal to 8 g/dl would be eligible for the study even if they are currently receiving blood products.
  7. Patients may receive up to 2 doses of aerosolized ribavirin (modified regimen) before enrollment into the study.
  8. Patients who will be enrolled on the observational arm should meet inclusion criteria # 2, 3, and 4 only.

Exclusion Criteria:

  1. Patients with previous history of hypersensitivity to ribavirin or its components
  2. Women who are pregnant or plan a pregnancy within 8 weeks after completion of treatment (only for patients who are going to be randomised to either therapeutic arms).
  3. Patients with evidence of RSV LRI as documented by a positive rapid RSV antigen testing and/or culture on nasal washes AND new or progressive infiltrates on chest radiographic studies suggestive of viral etiology and/or pulse oxygen less than 90 mm of Hg on room air.
  4. Patients with positive RSV by rapid antigen testing and/or culture in bronchoalveolar lavage regardless of the chest radiographic findings.
  5. Patients who are considered to be moderately or severely anemic as per the NCI classification will not be included in the study, i.e patients with hemoglobin level less than 8 g/dl
  6. Patient with Total Bilirubin and Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) three times the upper limit of normal.
  7. Male partners of women who are pregnant (only for patients who are going to be randomised to either therapeutic arms).
  8. Patients with known history of autoimmune hepatitis, Hepatitic C or those with hemoglobinopathies (eg, thalassemia major, sickle cell anemia).
  9. Patients with creatinine clearance of less than or equal to 50 ml/Min
  10. Patients taking didanosine, azathioprine, or nucleoside reverse transcriptase inhibitors
  11. Patients who will be enrolled on the observational arm should not meet exclusion criteria #3 and 4 only.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01502072

Contacts
Contact: Roy F. Chemaly, MD 713-792-0007

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Roy F. Chemaly, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01502072     History of Changes
Other Study ID Numbers: 2011-0813
Study First Received: December 22, 2011
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Ribavirin
Ribavirin Aerosol
Respiratory Syncytial Virus
RSV
upper respiratory tract infection
URI
Lower respiratory tract Infection
LRI
pneumonia
aerosolized ribavirin
HSCT
Hematopoietic stem cell transplantation
oral ribavirin therapy

Additional relevant MeSH terms:
Leukemia
Pneumonia
Respiratory Syncytial Virus Infections
Respiratory Tract Infections
Virus Diseases
Neoplasms by Histologic Type
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Infection
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014