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

C

Capital Medical University

Status and phase

Unknown
Phase 4

Conditions

Pulmonary Candidiasis

Treatments

Drug: fluconazole

Study type

Interventional

Funder types

Other

Identifiers

NCT00537888
CYH-CMU

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

14 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Bin Cao, doctor

Data sourced from clinicaltrials.gov

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