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

Diagnosis of Pulmonary Candidiasis

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Candidiasis
• Intervention / Treatment: Drug: fluconazole

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Recruiting
      • Beijing Chaoyang Hospital,Affiliate of Capital Medical University
      • Contact: Bin Cao, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
invasive candidiasis	in hospital

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Principal Investigator: Bin Cao, Doctor, Beijing Chaoyang Hospital, Affiliate of Capital Medical University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: October 1, 2007
• First Submitted That Met QC Criteria: October 1, 2007
• First Posted (Estimate): October 2, 2007

Study Record Updates

• Last Update Posted (Estimate): December 14, 2010
• Last Update Submitted That Met QC Criteria: December 13, 2010
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Candidiasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluconazole
• Other Study ID Numbers: CYH-CMU