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NCT00986713 Clinical Trial

Value of Amphotericin B Inhalation for Prophylaxis of Invasive Pulmonary Aspergillosis After Renal Transplantation

Invasive Pulmonary Aspergillosis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00986713
Other study ID # CYH-CMU AmB Neph
Secondary ID
Status Recruiting
Phase Phase 4
First received September 29, 2009
Last updated September 29, 2009
Start date June 2008
Est. completion date October 2010

Study information
Verified date September 2009
Source Capital Medical University
Contact n/a
Is FDA regulated No
Health authority China:Beijing Chaoyang Hospital,Affiliate of Capital Medical University
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date October 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Amphotericin B
Aerosolized Amphotericin B,2mg/day or 10mg/day

Locations
Country Name City State
China Beijing Chaoyang Hospital,Affiliate of Capital Medical University Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary invasive pulmonary aspergillosis 3 years Yes
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