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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Capital Medical University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00986713
First Posted: September 30, 2009
Last Update Posted: September 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Capital Medical University
  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 4

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

Resource links provided by NLM:


Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • invasive pulmonary aspergillosis [ Time Frame: 3 years ]

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:
    Drug: Amphotericin B
    Aerosolized Amphotericin B,2mg/day or 10mg/day
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 29, 2009
First Posted: September 30, 2009
Last Update Posted: September 30, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Aspergillosis
Pulmonary Aspergillosis
Invasive Pulmonary Aspergillosis
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases
Amphotericin B
Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents