search
Back to results

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
Capital Medical University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Invasive Pulmonary Aspergillosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 29, 2009
Last Updated
September 29, 2009
Sponsor
Capital Medical University
search

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

We'll reach out to this number within 24 hrs