Value of Amphotericin B Inhalation for Prophylaxis of Invasive Pulmonary Aspergillosis After Renal Transplantation
1 other identifier
interventional
400
1 country
1
Brief Summary
The purpose of this study is to determine whether inhalation with aerosolized amphoterin B 10mg/d is more effective than aerosolized amphoterin B 2mg/d to reduce the incidence of invasive pulmonary aspergillosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 29, 2009
CompletedFirst Posted
Study publicly available on registry
September 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedSeptember 30, 2009
September 1, 2009
2.3 years
September 29, 2009
September 29, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
invasive pulmonary aspergillosis
3 years
Interventions
Aerosolized Amphotericin B,2mg/day or 10mg/day
Eligibility Criteria
You may qualify if:
- ys≥age≥18ys
- renal transplant recipients
You may not qualify if:
- subjects with hypersensitivity to amphotericin B
- receipt of inhalational or intravenous amphotericin B within last 30 days
- subjects with known invasive fungal infection before renal transplant
- subjects with pneumonia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Chaoyang Hospital,Affiliate of Capital Medical University
Beijing, Beijing Municipality, 100020, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 29, 2009
First Posted
September 30, 2009
Study Start
June 1, 2008
Primary Completion
September 1, 2010
Study Completion
October 1, 2010
Last Updated
September 30, 2009
Record last verified: 2009-09