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
Sponsor:
Information provided by:
Capital Medical University
ClinicalTrials.gov Identifier:
NCT00986713
First received: September 29, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ 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:
    Drug: Amphotericin B
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014