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A Retrospective Study Evaluating the Efficacy and Safety of Micafungin Sodium in the Treatment of Invasive Fungal Infections

A Retrospective Study Evaluating the Efficacy and Safety of Micafungin Sodium in the Treatment of Invasive Fungal Infections

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02678598
Enrollment
2555
Registered
2016-02-10
Start date
2015-03-31
Completion date
2015-08-31
Last updated
2016-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Fungal Infections

Keywords

Micafungin, Candida, Aspergillosis, Antifungal

Brief summary

The objective of this study is to evaluate the efficacy of intravenous micafungin for the empirical antifungal therapy, pre-emptive antifungal therapy, diagnostic driven antifungal therapy or targeted antifungal therapy patients with invasive fungal infections caused by Candida sp. or Aspergillus sp. (fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.

Interventions

DRUGMicafungin

Intravenous

Sponsors

Astellas Pharma China, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients who received Micafungin as empirical antifungal therapy, pre-emptive antifungal therapy, diagnostic driven antifungal therapy or targeted antifungal therapy * Patients received Micafungin treatment at least 1 dose

Exclusion criteria

* Patients received Micafungin treatment combined with other antifungal drugs at the same time * Neither efficacy or safety can be evaluated because of missing data, confused record

Design outcomes

Primary

MeasureTime frameDescription
Overall success rateUp to 12 monthsOverall success rate=number of overall success patients/number of patients for efficacy evaluation × 100%

Secondary

MeasureTime frame
Overall incidence and severity of adverse eventsUp to 12 months
Overall incidence and severity of adverse drug reactionsUp to 12 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026