Trial record 2 of 39 for:    Open Studies | "Candidiasis"

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

This study is currently recruiting participants.
Verified November 2013 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma China, Inc. )
ClinicalTrials.gov Identifier:
NCT01982071
First received: November 6, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  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
Candidiasis
Candidemia
Drug: Micafungin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 109
Study Start Date: September 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group Drug: Micafungin
IV

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01982071

Contacts
Contact: Clinical Development Administration Dept. clintrialtrials_info@jp.astellas.com

Locations
China
Recruiting
Beijing, China
Recruiting
Changsha, China
Recruiting
Chengdu, China
Recruiting
Fuzhou, China
Recruiting
Guangzhou, China
Recruiting
Harbin, China
Recruiting
Hengyang, China
Recruiting
Jinan, China
Recruiting
Nanjing, China
Recruiting
Shanghai, China
Recruiting
Shaoyang, China
Recruiting
Shenyang, China
Recruiting
Tianjin, China
Recruiting
Xi'an, China
Recruiting
Xiamen, China
Sponsors and Collaborators
Astellas Pharma China, Inc.
Investigators
Principal Investigator: Medical Director Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( 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: November 6, 2013
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 17, 2014