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

Sponsor

Kyoto University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00304772

Collaborator

Pfizer (Industry), Astellas Pharma Inc (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Candidiasis Sepsis	Drug: Fluconazole Drug: Micafungin	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized Comparative Study of Fluconazole Versus Micafungin for the Treatment of Candida Bloodstream Infection in Non-Neutropenic Patients

Study Start Date :

Aug 1, 2006

Anticipated Primary Completion Date :

Dec 1, 2008

Anticipated Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1	Drug: Fluconazole 400mg/day
Active Comparator: 2	Drug: Micafungin 150mg/day

Arm

Intervention/Treatment

Active Comparator: 1

Drug: Fluconazole

400mg/day

Active Comparator: 2

Drug: Micafungin

150mg/day

Outcome Measures

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) [12 weeks and 4 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Laboratory Medicine, Kyoto University Hospital	Kyoto		Japan	606-8507

Sponsors and Collaborators

Kyoto University
Pfizer
Astellas Pharma Inc

Investigators

Study Chair: Satoshi Ichiyama, MD, PhD, Professor of Medicine, Department of Clinical Laboratory Medicine, Kyoto University Hospital
Principal Investigator: Shunji Takakura, MD, PhD, Instructor in Medicine, Department of Clinical Laboratory Medicine, Kyoto University Hospital