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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Progression to Lower Respiratory Tract Infection (LRI)
研究概览
简要总结
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.
详细描述
Study Groups:
If you are found to be eligible to take part in this study and the study doctor thinks that the disease requires treatment at this time, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group:
- If you are in Group 1, you will receive the inhaled form of ribavirin. You will inhale ribavirin 3 times a day for 3 hours each time in a tent in a hospital room. You will receive the drug for up to 10 days.
- If you are in Group 2, you will take capsules of ribavirin 3 times a day for up to 10 days.
If the study doctor does not think that the disease requires treatment at this time, you will be assigned to Group 3. If you are in Group 3, you will not receive treatment with ribavirin, but you will have the same tests and procedures at the study visits described below.
Study Visits:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
- •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).
- •Patients must be at least 18 years of age and able to swallow pills.
- •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.
- •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).
- •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.
- •Patients may receive up to 2 doses of aerosolized ribavirin (modified regimen) before enrollment into the study.
- •Patients who will be enrolled on the observational arm should meet inclusion criteria # 2, 3, and 4 only.
排除标准
- •Patients with previous history of hypersensitivity to ribavirin or its components
- •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).
- •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.
- •Patients with positive RSV by rapid antigen testing and/or culture in bronchoalveolar lavage regardless of the chest radiographic findings.
- •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
- •Patient with Total Bilirubin and Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) three times the upper limit of normal.
- •Male partners of women who are pregnant (only for patients who are going to be randomised to either therapeutic arms).
- •Patients with known history of autoimmune hepatitis, Hepatitic C or those with hemoglobinopathies (eg, thalassemia major, sickle cell anemia).
- •Patients with creatinine clearance of less than or equal to 50 ml/Min
- •Patients taking didanosine, azathioprine, or nucleoside reverse transcriptase inhibitors
- •Patients who will be enrolled on the observational arm should not meet exclusion criteria #3 and 4 only.
研究组 & 干预措施
Inhaled Ribavirin
Group 1: Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.
干预措施: Ribavirin (Drug)
Oral Ribavirin
Group 2: Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants With Progression to Lower Respiratory Tract Infection (LRI)
时间窗: 14 days
Patient who developed signs of lower respiratory tract infection
次要结局
未报告次要终点