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

Sponsor
Astellas Pharma China, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT01982071
Collaborator
(none)
59
Enrollment
15
Locations
1
Arm
23
Actual Duration (Months)
3.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
59 participants
Allocation:
N/A
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)
Actual Study Start Date :
Sep 26, 2013
Actual Primary Completion Date :
Aug 28, 2015
Actual Study Completion Date :
Aug 28, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group

Intravenous (IV)

Drug: Micafungin
Intravenous (IV)

Outcome Measures

Primary Outcome Measures

  1. Overall success rate [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 [up to 10 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Beijing China
2 Changsha China
3 Chengdu China
4 Fuzhou China
5 Guangzhou China
6 Harbin China
7 Hengyang China
8 Jinan China
9 Nanjing China
10 Shanghai China
11 Shaoyang China
12 Shenyang China
13 Tianjin China
14 Xi'an China
15 Xiamen China

Sponsors and Collaborators

  • Astellas Pharma China, Inc.

Investigators

  • Principal Investigator: Medical Director, Astellas Pharma Inc

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Astellas Pharma China, Inc.
ClinicalTrials.gov Identifier:
NCT01982071
Other Study ID Numbers:
  • ACN-MA-MYC-IC-2012
First Posted:
Nov 13, 2013
Last Update Posted:
Dec 20, 2018
Last Verified:
Dec 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Astellas Pharma China, Inc.
Micafungin
candidiasis
candidemia
Open-label design
Additional relevant MeSH terms:
Candidiasis
Candidemia
Candidiasis, Invasive
Micafungin

Study Results

No Results Posted as of Dec 20, 2018