CompletedPhase 2NCT01502072
Official study title

Respiratory Syncytial Virus - RSV Protocol

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedRibavirin and Ribavirin

The study team can explain what participation involves.

Who it may be forBone Marrow Transplant Infection · Infection in Marrow Transplant Recipients

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 15, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?M.D. Anderson Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
M.D. Anderson Cancer Center
Interventions being studied
Drug: Ribavirin; Drug: Ribavirin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Texas MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 15, 2021. Always confirm current availability with the study team.

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