Respiratory Syncytial Virus - RSV Protocol
Condition: Bone Marrow Transplant Infection; Infection in Marrow Transplant Recipients; Respiratory Syncytial Virus Infections; Respiratory Syncytial Virus Pneumonia; Cancer; Acute Leukemia
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Pneumonia; Respiratory Tract Infections; Respiratory Syncytial Virus Infections
Intervention: Ribavirin; Ribavirin
Intervention description: 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.; 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).
Intervention MeSH terms: Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. HSCT patients with either moderate or severe 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 mild 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.