Clinical Significance of Smear or Culture Positive for Candida Spp. From Sputum Three Times a Week

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Capital Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Capital Medical University
ClinicalTrials.gov Identifier:
NCT00537888
First received: October 1, 2007
Last updated: December 13, 2010
Last verified: July 2009
  Purpose

The definition of pulmonary candidiasis is still unclear.In China, isolation of candida spp. form sputum twice or three times a week has been regarded as the microbiological evidence of pulmonary candidiasis. The investigators hypothesize that patients who present respiratory symptoms and lung infiltrates together with smear of culture positive for candida spp. from sputum three times a week can not be diagnosed as pulmonary candidiasis.


Condition Intervention Phase
Pulmonary Candidiasis
Drug: fluconazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diagnosis of Pulmonary Candidiasis

Resource links provided by NLM:


Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • invasive candidiasis [ Time Frame: in hospital ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: September 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: fluconazole
    Intravenous or oral 400 md/d
  Eligibility

Ages Eligible for Study:   14 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 85ys>age>14ys
  • APACHE II<25
  • Lung infiltrates together with at least one of the following symptoms:cough, sputum, dyspnea with or without fever
  • smear or culture positive for candida spp. from sputum

Exclusion Criteria:

  • Pregnancy
  • Hypersensitivity to fluconazole
  • Isolated candida was non-sensitive to fluconazole
  • Severe liver or renal diseases who can not tolerate fluconazole treatment
  • With at least one of the following high risk factors:organ transplantation, neutropenia>10ds, long term glucocorticoids therapy(equal to prednisone 30mg/d longer than 2 weeks), immunosuppressive therapy within 30ds, AIDS
  • With one of the microbiological evidence:isolation of candida spp. from blood or other kinds of sterile site(not including urine), filamentous fungi isolated from sputum or BALF, cryptococcus isolated from sputum or CSF, galactomannan antigen positive twice for blood
  • Probable or possible pulmonary aspergillosis
  • Definite oral or esophageal candidiasis
  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: NCT00537888

Contacts
Contact: Bin Cao, doctor 8610-85231130 caobin1999@gmail.com

Locations
China, Beijing
Beijing Chaoyang Hospital,Affiliate of Capital Medical University Recruiting
Beijing, Beijing, China, 100020
Contact: Bin Cao, doctor         
Sponsors and Collaborators
Capital Medical University
Investigators
Principal Investigator: Bin Cao, Doctor Beijing Chaoyang Hospital, Affiliate of Capital Medical University
  More Information

Publications:
Responsible Party: Capital Medical University, Beijing Chaoyang Hospital
ClinicalTrials.gov Identifier: NCT00537888     History of Changes
Other Study ID Numbers: CYH-CMU
Study First Received: October 1, 2007
Last Updated: December 13, 2010
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Candidiasis
Mycoses
Fluconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014