Value of Amphotericin B Inhalation for Prophylaxis of Invasive Pulmonary Aspergillosis After Renal Transplantation
Primary Purpose
Invasive Pulmonary Aspergillosis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Amphotericin B
Sponsored by
About this trial
This is an interventional prevention trial for Invasive Pulmonary Aspergillosis
Eligibility Criteria
Inclusion Criteria:
- 65ys≥age≥18ys
- renal transplant recipients
Exclusion Criteria:
- 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
Sites / Locations
- Beijing Chaoyang Hospital,Affiliate of Capital Medical UniversityRecruiting
Outcomes
Primary Outcome Measures
invasive pulmonary aspergillosis
Secondary Outcome Measures
Full Information
NCT ID
NCT00986713
First Posted
September 29, 2009
Last Updated
September 29, 2009
Sponsor
Capital Medical University
1. Study Identification
Unique Protocol Identification Number
NCT00986713
Brief Title
Value of Amphotericin B Inhalation for Prophylaxis of Invasive Pulmonary Aspergillosis After Renal Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
October 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Capital Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Pulmonary Aspergillosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Amphotericin B
Intervention Description
Aerosolized Amphotericin B,2mg/day or 10mg/day
Primary Outcome Measure Information:
Title
invasive pulmonary aspergillosis
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
65ys≥age≥18ys
renal transplant recipients
Exclusion Criteria:
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
Facility Information:
Facility Name
Beijing Chaoyang Hospital,Affiliate of Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Cao, doctor
Phone
8610-85231130
Email
caobin1999@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Value of Amphotericin B Inhalation for Prophylaxis of Invasive Pulmonary Aspergillosis After Renal Transplantation
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