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Fluconazole Versus Micafungin for Candida Bloodstream Infection in Non-Neutropenic Patients

Primary Purpose

Candidiasis, Sepsis

Status
Withdrawn
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Fluconazole
Micafungin
Sponsored by
Kyoto University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis focused on measuring Candida, bloodstream infection, fluconazole, micafungin, randomized controlled trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients in whom Candida species have been isolated from blood culture. Patients accompanied by systemic infectious symptoms during the period from 24 hours (h) before collection of blood culture showing a positive result. Patients aged 20 years or older on the date of registration. Patients who have not received systemic administration of antifungal agents or who have started such administration within 48 h. Patients in whom a central venous (CV) catheter has been removed during the period from 24 h before collection of blood culture showing a positive result to registration, or a CV catheter can be removed within 72 h after registration. Patients with no verified undrainable abscess with a diameter of at least 3 cm, or impassable occlusive lesions, which are possibly attributable to Candida species. Patients from whom written informed consent to participate in this study has been obtained (or from their legally acceptable representatives). Patients who have adequate neutrophil count and hepatic/renal function in the blood test performed within 72 h before registration. Exclusion Criteria: Patients with a history of adverse reactions associated with fluconazole or micafungin. Patients who have been treated with fluconazole or micafungin for at least 1 week within 12 weeks. Patients with a history of detection of fluconazole non-susceptible Candida species within 12 weeks. Patients in whom the neutrophil count is predicted to decrease to below 500/mL. Patients who are not treated with terfenadine, triazolam, cisapride, and ergotamine, which are contraindicated for concomitant use with fluconazole. Patients who are determined to be ineligible by the investigator.

Sites / Locations

  • Department of Clinical Laboratory Medicine, Kyoto University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Treatment success (completion of protocol treatment within 12 weeks and recurrence-free survival at 4 weeks after the completion of protocol treatment)

Secondary Outcome Measures

Safety
Duration of protocol treatment period in patients with treatment success
Overall survival at 4 and 12 weeks
Recurrence in patients who completed protocol treatment
Occurrence and deterioration of endophthalmitis during protocol treatment
Treatment success according to causative species, antifungal susceptibility profile, underlying condition

Full Information

First Posted
March 17, 2006
Last Updated
March 14, 2017
Sponsor
Kyoto University
Collaborators
Pfizer, Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00304772
Brief Title
Fluconazole Versus Micafungin for Candida Bloodstream Infection in Non-Neutropenic Patients
Official Title
A Randomized Comparative Study of Fluconazole Versus Micafungin for the Treatment of Candida Bloodstream Infection in Non-Neutropenic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Subjects were not recruited as intended.
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyoto University
Collaborators
Pfizer, Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to verify the equivalence in clinical efficacy of fluconazole and micafungin for the treatment of Candida bloodstream infection in non-neutropenic patients.
Detailed Description
Candida bloodstream infection occurs in patients with poor general conditions and has poor prognosis with attributable mortality of more than 30%. Clinical efficacy of fluconazole for the treatment of Candida bloodstream infection has been reported in clinical studies, since 1985 when it placed on the market. Fluconazole has established a position as the first-line drug up to date. However, possibly associated with the increased use of fluconazole, increased frequency of Candida species or strains with low susceptibility to fluconazole has been pointed out. Micafungin, an antifungal echinocandin with a different antifungal mechanism from fluconazole, has been reported to show good in vitro activity to various Candida species and strains with fluconazole resistance, and has comparative clinical efficacy with fluconazole for esophageal candidiasis, while it has relatively low in vitro activity to certain Candida species. There is no comparative study of fluconazole versus micafungin against Candida bloodstream infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Sepsis
Keywords
Candida, bloodstream infection, fluconazole, micafungin, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Intervention Description
400mg/day
Intervention Type
Drug
Intervention Name(s)
Micafungin
Intervention Description
150mg/day
Primary Outcome Measure Information:
Title
Treatment success (completion of protocol treatment within 12 weeks and recurrence-free survival at 4 weeks after the completion of protocol treatment)
Time Frame
12 weeks and 4 weeks
Secondary Outcome Measure Information:
Title
Safety
Time Frame
12 weeks and 4 weeks
Title
Duration of protocol treatment period in patients with treatment success
Time Frame
12 weeks and 4 weeks
Title
Overall survival at 4 and 12 weeks
Time Frame
12 weeks and 4 weeks
Title
Recurrence in patients who completed protocol treatment
Time Frame
12 weeks and 4 weeks
Title
Occurrence and deterioration of endophthalmitis during protocol treatment
Time Frame
12 weeks and 4 weeks
Title
Treatment success according to causative species, antifungal susceptibility profile, underlying condition
Time Frame
12 weeks and 4 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients in whom Candida species have been isolated from blood culture. Patients accompanied by systemic infectious symptoms during the period from 24 hours (h) before collection of blood culture showing a positive result. Patients aged 20 years or older on the date of registration. Patients who have not received systemic administration of antifungal agents or who have started such administration within 48 h. Patients in whom a central venous (CV) catheter has been removed during the period from 24 h before collection of blood culture showing a positive result to registration, or a CV catheter can be removed within 72 h after registration. Patients with no verified undrainable abscess with a diameter of at least 3 cm, or impassable occlusive lesions, which are possibly attributable to Candida species. Patients from whom written informed consent to participate in this study has been obtained (or from their legally acceptable representatives). Patients who have adequate neutrophil count and hepatic/renal function in the blood test performed within 72 h before registration. Exclusion Criteria: Patients with a history of adverse reactions associated with fluconazole or micafungin. Patients who have been treated with fluconazole or micafungin for at least 1 week within 12 weeks. Patients with a history of detection of fluconazole non-susceptible Candida species within 12 weeks. Patients in whom the neutrophil count is predicted to decrease to below 500/mL. Patients who are not treated with terfenadine, triazolam, cisapride, and ergotamine, which are contraindicated for concomitant use with fluconazole. Patients who are determined to be ineligible by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satoshi Ichiyama, MD, PhD
Organizational Affiliation
Professor of Medicine, Department of Clinical Laboratory Medicine, Kyoto University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shunji Takakura, MD, PhD
Organizational Affiliation
Instructor in Medicine, Department of Clinical Laboratory Medicine, Kyoto University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Laboratory Medicine, Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan

12. IPD Sharing Statement

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Fluconazole Versus Micafungin for Candida Bloodstream Infection in Non-Neutropenic Patients

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