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Comparison study of liposomal amphotericin B and micafungin in treatment of deep candidasis in surgical and emergency domains

Phase 4
Conditions
Invasive Candidiasis
Registration Number
JPRN-UMIN000006106
Lead Sponsor
Department of Infection Control and Prevention, Aichi Medical University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
100
Inclusion Criteria

Not provided

Exclusion Criteria

(1) Cases treated with L-AMB or MCFG of those enrolled in this study. (2) Patients with a history of hypersensitivity to the ingredients of this product, such as shock (3) Children (younger than 16 years old) (4) Patients undergoing treatment (leukocyte transfusion) that is contraindicated for use in combination with L-AMB. (5)Pregnant or lactating patients or possibly pregnant patients. (6)Patients with a present illness of serious liver diseases not caused by infections or a past history of them. (7) Patients with neutrophil counts of <500 cells/mm3. (8)Patients with serious underlying diseases or infections who are not expected to live throughout the study period. (9) Other patients judged to be unsuitable as subjects by the physicians in charge

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clinical effect (efficacy ratio) at the end or discontinuation of administration Clinical symptoms between 4 and 7 days after the start of administration Clinical symptoms between 5 and 10 days after the end of administration
Secondary Outcome Measures
NameTimeMethod
Mycological effect Serological effect
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