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

This study is currently recruiting participants.

Verified by Capital Medical University, July 2009

First Received: October 1, 2007 Last Updated: July 31, 2009 History of Changes

Sponsored by:	Capital Medical University
Information provided by:	Capital Medical University
ClinicalTrials.gov Identifier:	NCT00537888

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 IV

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Placebo Control, Parallel Assignment, Bio-equivalence Study
Official Title:	Diagnosis of Pulmonary Candidiasis

Resource links provided by NLM:

MedlinePlus related topics: Yeast Infections

Drug Information available for: Fluconazole

U.S. FDA Resources

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 2009
Estimated Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Intervention Details:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537888

Contacts

Contact: Bin Cao, doctor

8610-85231130

caobin1999@gmail.com

Locations

China
Beijing Chaoyang Hospital,Affiliate of Capital Medical University	Recruiting
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:

Cao B, Cai BQ, Wang H, Zhou CY, Wang P, Liu HR, Zhang H, Xu L, Xu KF, Xu WB, Zhu YJ, Li XG. [A study of 152 cases of pulmonary fungal infection: reevaluation of the microbiological spectra] Zhonghua Jie He He Hu Xi Za Zhi. 2007 Apr;30(4):279-83. Chinese.

Responsible Party:	Beijing Chaoyang Hospital ( Capital Medical University )
Study ID Numbers:	CYH-CMU
Study First Received:	October 1, 2007
Last Updated:	July 31, 2009
ClinicalTrials.gov Identifier:	NCT00537888 History of Changes
Health Authority:	China: Ethics Committee

Study placed in the following topic categories:

Fluconazole
Anti-Infective Agents
Mycoses

Candidiasis
Antifungal Agents
Torulopsis

Additional relevant MeSH terms:

Fluconazole
Anti-Infective Agents
Mycoses
Candidiasis

Therapeutic Uses
Antifungal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009