Clinical Significance of Smear or Culture Positive for Candida Spp. From Sputum Three Times a Week
Diagnosis of Pulmonary Candidiasis
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2007
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 1, 2007
CompletedFirst Posted
Study publicly available on registry
October 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedDecember 14, 2010
July 1, 2009
3.3 years
October 1, 2007
December 13, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
invasive candidiasis
in hospital
Interventions
Intravenous or oral 400 md/d
Eligibility Criteria
You may qualify if:
- ys\>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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Chaoyang Hospital,Affiliate of Capital Medical University
Beijing, Beijing Municipality, 100020, China
Related 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.
PMID: 17651612RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bin Cao, Doctor
Beijing Chaoyang Hospital, Affiliate of Capital Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 1, 2007
First Posted
October 2, 2007
Study Start
September 1, 2007
Primary Completion
December 1, 2010
Study Completion
December 1, 2011
Last Updated
December 14, 2010
Record last verified: 2009-07