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

Pulmonary Candidiasis Clinical Trial

Official title:

Diagnosis of Pulmonary Candidiasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00537888
• Other study ID #: CYH-CMU
• Status: Recruiting
• Phase: Phase 4
• First received: October 1, 2007
• Last updated: December 13, 2010
• Start date: September 2007
• Est. completion date: December 2011

Study information

• Verified date: July 2009
• Source: Capital Medical University
• Contact: Bin Cao, doctor
• Phone: 8610-85231130
• Email: caobin1999[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Candidiasis
• Pulmonary Candidiasis

Intervention

Drug:
• fluconazole
Intravenous or oral 400 md/d

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital,Affiliate of Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	invasive candidiasis		in hospital	Yes