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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2009 by Capital Medical University. Recruitment status was Recruiting

First Received on September 29, 2009. No Changes Posted

Sponsor:	Capital Medical University
Information provided by:	Capital Medical University
ClinicalTrials.gov Identifier:	NCT00986713

Purpose

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	Intervention	Phase
Invasive Pulmonary Aspergillosis	Drug: Amphotericin B	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Aspergillosis

Drug Information available for: Amphotericin B

U.S. FDA Resources

Further study details as provided by Capital Medical University:

Primary Outcome Measures:

invasive pulmonary aspergillosis [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986713

Locations

China, Beijing
Beijing Chaoyang Hospital,Affiliate of Capital Medical University	Recruiting
Beijing, Beijing, China, 100020
Contact: Bin Cao, doctor 8610-85231130 caobin1999@gmail.com

Sponsors and Collaborators

Capital Medical University

More Information

No publications provided

Responsible Party:	Bin Cao,doctor, Beijing Chaoyang Hospital,Affiliate of Capital Medical Unibersity
ClinicalTrials.gov Identifier:	NCT00986713 History of Changes
Other Study ID Numbers:	CYH-CMU AmB Neph
Study First Received:	September 29, 2009
Last Updated:	September 29, 2009
Health Authority:	China:Beijing Chaoyang Hospital,Affiliate of Capital Medical University

Additional relevant MeSH terms:

Aspergillosis
Invasive Pulmonary Aspergillosis
Pulmonary Aspergillosis
Mycoses
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases
Amphotericin B
Liposomal amphotericin B

Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 09, 2012