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OpenTrials
Completed

NCT Number: NCT02678598

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Micafungin

Drug

Intravenous

Primary outcomes

  1. Overall success rate

    Time frame: Up to 12 months

    Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100%

Secondary outcomes

  1. Overall incidence and severity of adverse events

    Time frame: Up to 12 months

  2. Overall incidence and severity of adverse drug reactions

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Astellas Pharma China, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 10, 2016
Registry last updated
Feb 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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