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

Tracking Information

First Received Date ^ICMJE

October 1, 2007

Last Updated Date

July 31, 2009

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

invasive candidiasis [ Time Frame: in hospital ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00537888 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Diagnosis of Pulmonary Candidiasis

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Randomized, Open Label, Placebo Control, Parallel Assignment, Bio-equivalence Study

Condition ^ICMJE

Pulmonary Candidiasis

Intervention ^ICMJE

Drug: fluconazole

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

14 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Bin Cao, doctor

8610-85231130

caobin1999@gmail.com

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00537888

Responsible Party

Capital Medical University, Beijing Chaoyang Hospital

Study ID Numbers ^ICMJE

CYH-CMU

Study Sponsor ^ICMJE

Capital Medical University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Bin Cao, Doctor

Beijing Chaoyang Hospital, Affiliate of Capital Medical University

Information Provided By

Capital Medical University

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP