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

Primary Purpose

Pulmonary Candidiasis

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

fluconazole

About this trial

This is an interventional diagnostic trial for Pulmonary Candidiasis

Eligibility Criteria

14 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beijing Chaoyang Hospital,Affiliate of Capital Medical UniversityRecruiting

Outcomes

Primary Outcome Measures

invasive candidiasis

Secondary Outcome Measures

Full Information

NCT ID

NCT00537888

First Posted

October 1, 2007

Last Updated

December 13, 2010

Sponsor

Capital Medical University

1. Study Identification

Unique Protocol Identification Number

NCT00537888

Brief Title

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

Official Title

Diagnosis of Pulmonary Candidiasis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Unknown status

Study Start Date

September 2007 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Capital Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Candidiasis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

fluconazole

Intervention Description

Intravenous or oral 400 md/d

Primary Outcome Measure Information:

Title

invasive candidiasis

Time Frame

in hospital

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bin Cao, doctor

Phone

8610-85231130

caobin1999@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bin Cao, Doctor

Organizational Affiliation

Beijing Chaoyang Hospital, Affiliate of Capital Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Chaoyang Hospital,Affiliate of Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bin Cao, doctor

12. IPD Sharing Statement

Citations:

PubMed Identifier

17651612

Citation

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.

Results Reference

result

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

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