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

This study has been terminated.
(Due to administrative reasons)
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma China, Inc. )
ClinicalTrials.gov Identifier:
NCT01982071
First received: November 6, 2013
Last updated: March 7, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Candidemia
Candidiasis
Drug: Micafungin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Multi-center, Open-label, Non-comparative Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia (CFDA Commitment)

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Safety assessed by the incidence of adverse events [ Time Frame: up to 10 weeks ]

Enrollment: 59
Study Start Date: September 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group
Intravenous (IV)
Drug: Micafungin
Intravenous (IV)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01982071

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
Sponsors and Collaborators
Astellas Pharma China, Inc.
Investigators
Principal Investigator: Medical Director Astellas Pharma Inc
  More Information

Additional Information:
Responsible Party: Astellas Pharma China, Inc.
ClinicalTrials.gov Identifier: NCT01982071     History of Changes
Other Study ID Numbers: ACN-MA-MYC-IC-2012
Study First Received: November 6, 2013
Last Updated: March 7, 2017

Keywords provided by Astellas Pharma Inc:
Micafungin
candidiasis
candidemia
Open-label design

Additional relevant MeSH terms:
Candidiasis
Candidemia
Candidiasis, Invasive
Mycoses
Fungemia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Micafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 28, 2017