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

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ClinicalTrials.gov Identifier: NCT01982071
Recruitment Status : Terminated (Due to administrative reasons)
First Posted : November 13, 2013
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma China, Inc. )

Brief Summary:
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 or disease Intervention/treatment Phase
Candidemia Candidiasis Drug: Micafungin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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)
Study Start Date : September 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 :
  1. Safety assessed by the incidence of adverse events [ Time Frame: up to 10 weeks ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Astellas Pharma China, Inc.
ClinicalTrials.gov Identifier: NCT01982071     History of Changes
Other Study ID Numbers: ACN-MA-MYC-IC-2012
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017

Keywords provided by Astellas Pharma Inc ( Astellas Pharma China, Inc. ):
Micafungin
candidiasis
candidemia
Open-label design

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