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Clinical Trials/NCT00986713
NCT00986713UnknownPhase 4

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

Capital Medical University1 site in 1 country400 target enrollmentStarted: June 1, 2008Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Sponsor
Enrollment
400
Locations
1
Primary Endpoint
invasive pulmonary aspergillosis
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

invasive pulmonary aspergillosis

Time Frame: 3 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Capital Medical University
Sponsor Class
Other

Study Sites (1)

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