A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia

December 18, 2018 updated by: Astellas Pharma China, Inc.

A Multi-center, Open-label, Non-comparative Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia (CFDA Commitment)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
      • Changsha, China
      • Chengdu, China
      • Fuzhou, China
      • Guangzhou, China
      • Harbin, China
      • Hengyang, China
      • Jinan, China
      • Nanjing, China
      • Shanghai, China
      • Shaoyang, China
      • Shenyang, China
      • Tianjin, China
      • Xi'an, China
      • Xiamen, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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:

    1. Risk factor (s) of infection
    2. Clinical manifestations of infection and the pulmonary infection cannot be explained by other pathogenic infections
    3. Two or more positive sputum culture for Candida

Exclusion Criteria:

  • Patient received any other antifungal drug within 1 month prior to enrollment.
  • HIV positive patient
  • Patients with organ transplant
  • Patients with agranulocytosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Intravenous (IV)
Drug: Micafungin
Intravenous (IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall success rate
Time Frame: up to 8 weeks
success rate is calculated as (number of success patients/number of patients for efficacy evaluation × 100% at end of treatment)
up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety assessed by the incidence of adverse events
Time Frame: up to 10 weeks
up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma China, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2013

Primary Completion (Actual)

August 28, 2015

Study Completion (Actual)

August 28, 2015

Study Registration Dates

First Submitted

November 6, 2013

First Submitted That Met QC Criteria

November 6, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Actual)

December 20, 2018

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACN-MA-MYC-IC-2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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."

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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