Clinical trial · Interventional
Intermittent Use of Aerosolized Ribavirin for Treatment of RSV
A Randomized Study Evaluating Two Different Schedules of Aerosolized Ribavirin For Treatment of RSV Upper Respiratory Infections in Patients With Hematological Malignancies
NCT00500578CI-TRIAL-00007663completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ribavirin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1: Standard Schedule - Ribavirin
- description
- Aerosolized Ribavirin 6 grams over 18 hours every 24 hours
- interventionNames
- Drug: Ribavirin
- type
- EXPERIMENTAL
- label
- 2: Modified Schedule - Ribavirin
- description
- Aerosolized Ribavirin 2 grams over 3 hours every 8 hours
- interventionNames
- Drug: Ribavirin
Primary outcomes (1)
- measure
- Occurrences of Pneumonia
- timeFrame
- 6 Years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDChemaly RF, Torres HA, Munsell MF, Shah DP, Rathod DB, Bodey GP, Hosing C, Saifan C, Raad II, Champlin RE. An adaptive randomized trial of an intermittent dosing schedule of aerosolized ribavirin in patients with cancer and respiratory syncytial virus infection. J Infect Dis. 2012 Nov;206(9):1367-71. doi: 10.1093/infdis/jis516. Epub 2012 Aug 22. PMID 22927454