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

This study is currently recruiting participants.

Verified by Capital Medical University, September 2009

First Received: 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:	Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

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

Additional relevant MeSH terms:

Abelcet
Anti-Infective Agents
Amphotericin B
Antiprotozoal Agents
Immune System Diseases
Aspergillosis, Allergic Bronchopulmonary
Aspergillosis
Liposomal amphotericin B
Pharmacologic Actions
Anti-Bacterial Agents
Mycoses
Antiparasitic Agents

Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Antifungal Agents
Therapeutic Uses
Lung Diseases
Antibiotics, Antifungal
Hypersensitivity, Immediate
Amebicides
Lung Diseases, Fungal
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010