Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant

• Register: ClinicalTrials.gov
• Last refreshed on: 26 October 2021
• Main ID: NCT01432080
• Date of registration: 08/09/2011
• Prospective Registration: No
• Primary sponsor: Maisonneuve-Rosemont Hospital
• Public title: Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant
• Scientific title: Does Increasing Immunosuppression Prevent Transplant-associated Lung-disease Triggered by Viral Respiratory Tract Infection Following Allogeneic Stem Cell Transplant? A Pilot Study
• Date of first enrolment: September 2011
• Target sample size: 12
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01432080
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Elizabeth F Krakow, MD,CM, FRCPC
• Affiliation: Maisonneuve-Rosemont Hospital

• Name: Sandra Cohen, MD, FRCPC
• Affiliation: Maisonneuve-Rosemont Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Respiratory Tract Infections

Bronchiolitis Obliterans

Cryptogenic Organizing Pneumonia

Lung Diseases, Interstitial

Intervention(s)

Drug: Montelukast

Drug: Azithromycin

Drug: Symbicort

Drug: Prednisone

Primary Outcome(s)

Cumulative incidence of new chronic lung disease [Time Frame: 6 months following diagnosis of the viral respiratory tract infection]

Secondary Outcome(s)

Cumulative incidence of death from other causes [Time Frame: 6 months post enrolment]

Incidence of various other infectious complications [Time Frame: Within 6 months after enrolment]

Cumulative incidence of death attributable to transplant associated lung disease [Time Frame: 6 months post enrolment]

Overall survival at 1 year post-transplant [Time Frame: 1 year post-transplant]

Incidence of progression to respiratory failure [Time Frame: 21 days after enrolment]

Patient-perceived long-term functional impairment [Time Frame: 6 months post viral respiratory tract infection]

Time to clearance of viral infection [Time Frame: Every 2 weeks until virus is no longer detectable]

Overall survival from date of viral respiratory tract infection [Time Frame: 6 months post enrolment]

Overall survival from date of transplant to end of study follow-up [Time Frame: 6 months post enrolment]

Overall survival from date of viral respiratory tract infection [Time Frame: 3 months post enrolment]

Long-term functional impairment as defined by need for supplemental oxygen [Time Frame: 6 months post viral respiratory tract infection]

Incidence of bacterial or fungal superinfection [Time Frame: Within 21 days after enrolment]

Prevalence of non-infectious pulmonary complications [Time Frame: 6 months following the diagnosis of viral respiratory tract infection]

Secondary ID(s)

HMR1102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Canadian Blood and Marrow Transplant Group