A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia
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ClinicalTrials.gov Identifier: NCT01982071
Recruitment Status :
(Due to administrative reasons)
First Posted : November 13, 2013
Last Update Posted : December 20, 2018
Astellas Pharma China, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma China, Inc. )
To evaluate the efficacy and safety of intravenous micafungin for the treatment of patients with proven or probable fungal infections caused by Candida sp. (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The diagnosis criteria of probable candida infection: Risk factors + Clinical Manifestations + positive findings including microbiologic test
The diagnosis criteria of proven candida infection: Risk factors + Clinical Manifestation + positive findings including microbiologic test + tissue culture or pathological examination results
The following 3 criteria must be met is a patient is diagnosed as probable candida pneumonia:
Risk factor (s) of infection
Clinical manifestations of infection and the pulmonary infection cannot be explained by other pathogenic infections
Two or more positive sputum culture for Candida
Patient received any other antifungal drug within 1 month prior to enrollment.
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Keywords provided by Astellas Pharma Inc ( Astellas Pharma China, Inc. ):