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

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 July 2009 by Capital Medical University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00537888
First Posted: October 2, 2007
Last Update Posted: December 14, 2010
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 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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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
First Submitted: October 1, 2007
First Posted: October 2, 2007
Last Update Posted: December 14, 2010
Last Verified: July 2009

Additional relevant MeSH terms:
Candidiasis
Mycoses
Fluconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors


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