Status:
TERMINATED
Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant
Lead Sponsor:
Maisonneuve-Rosemont Hospital
Collaborating Sponsors:
The Canadian Blood and Marrow Transplant Group
Conditions:
Respiratory Tract Infections
Bronchiolitis Obliterans
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
For many patients with blood cancers, stem cell transplantation from a family member or from an unrelated donor remains the only potentially curative option. Unfortunately, up to 40% of patients devel...
Eligibility Criteria
Inclusion
- Allogeneic transplant within the prior 1 year
- Age greater than or equal to 18 years
- Capable of informed consent
- Neutrophil engraftment has occurred
- This is the first clinically-recognized episode of viral respiratory tract infection after transplant
Exclusion
- Proof or high suspicion for bacterial, fungal or any non-viral microorganism causing pneumonia
- CMV, VZV or HSV pneumonia
- Prior diagnosis of a chronic transplant-related non-infectious pulmonary complication (ex: BO, COP)
- Treating physician believes the risk of systemic steroids is too great
- Currently receiving prednisone at or greater than 0.25 mg/kg/day or the equivalent dose of another steroid
- Currently receiving pentostatin
- Mycophenolate initiated de novo or increased within the past 4 weeks
- Use of inhaled corticosteroids within the past 2 weeks for at least 1 week
- Haploidentical or T-cell depleted graft
- Lack of pre-transplant pulmonary function tests
- Evidence of a prior symptomatic viral respiratory tract infection following transplant, whether treated or not
- Allergy or adverse reaction to any of the study drugs
- Relapse or progression of the underlying malignancy
- Palliative care
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01432080
Start Date
September 1 2011
End Date
December 30 2013
Last Update
October 20 2021
Active Locations (1)
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1
Maisonneuve-Rosemont Hospital (Hôpital Maisonneuve-Rosemont)
Montreal, Quebec, Canada, H1T 2M4