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

NCT ID: NCT00986713

Last Updated: 2009-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Invasive Pulmonary Aspergillosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Interventions

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Amphotericin B

Aerosolized Amphotericin B,2mg/day or 10mg/day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Beijing Chaoyang Hospital,Affiliate of Capital Medical Unibersity

Locations

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Beijing Chaoyang Hospital,Affiliate of Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Bin Cao, doctor

Role: primary

Other Identifiers

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CYH-CMU AmB Neph

Identifier Type: -

Identifier Source: org_study_id