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

• Sponsor: Capital Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00986713
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Duration (Months): 28
• Patients Per Site Per Month: 14.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Invasive Pulmonary Aspergillosis	Drug: Amphotericin B	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Study Start Date: Jun 1, 2008
• Anticipated Primary Completion Date: Sep 1, 2010
• Anticipated Study Completion Date: Oct 1, 2010

Outcome Measures

Primary Outcome Measures

1. invasive pulmonary aspergillosis [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Chaoyang Hospital,Affiliate of Capital Medical University	Beijing	Beijing	China	100020

Sponsors and Collaborators

• Capital Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00986713
• Other Study ID Numbers: CYH-CMU AmB Neph
• First Posted: Sep 30, 2009
• Last Update Posted: Sep 30, 2009
• Last Verified: Sep 1, 2009

• Additional relevant MeSH terms: Aspergillosis; Pulmonary Aspergillosis; Invasive Pulmonary Aspergillosis; Amphotericin B; Liposomal amphotericin B

Study Results

No Results Posted as of Sep 30, 2009