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

NCT ID: NCT00537888

Last Updated: 2010-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Candidiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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fluconazole

Intravenous or oral 400 md/d

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Beijing Chaoyang Hospital

Principal Investigators

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Bin Cao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Chaoyang Hospital, Affiliate of Capital Medical University

Locations

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Beijing Chaoyang Hospital,Affiliate of Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bin Cao, doctor

Role: CONTACT

Phone: 8610-85231130

Email: [email protected]

Facility Contacts

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Bin Cao, doctor

Role: primary

References

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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.

Reference Type RESULT
PMID: 17651612 (View on PubMed)

Other Identifiers

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CYH-CMU

Identifier Type: -

Identifier Source: org_study_id