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

Sponsors and Collaborators:	Kyoto University Pfizer Astellas Pharma Inc
Information provided by:	Kyoto University
ClinicalTrials.gov Identifier:	NCT00304772

Purpose

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	Intervention	Phase
Candidiasis Sepsis	Drug: Fluconazole Drug: Micafungin	Phase IV

MedlinePlus related topics: Sepsis Yeast Infections

Drug Information available for: Fluconazole Micafungin FK 463

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Comparative Study of Fluconazole Versus Micafungin for the Treatment of Candida Bloodstream Infection in Non-Neutropenic Patients

Further study details as provided by Kyoto University:

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) [ Time Frame: 12 weeks and 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: 12 weeks and 4 weeks ] [ Designated as safety issue: Yes ]
Duration of protocol treatment period in patients with treatment success [ Time Frame: 12 weeks and 4 weeks ] [ Designated as safety issue: No ]
Overall survival at 4 and 12 weeks [ Time Frame: 12 weeks and 4 weeks ] [ Designated as safety issue: No ]
Recurrence in patients who completed protocol treatment [ Time Frame: 12 weeks and 4 weeks ] [ Designated as safety issue: No ]
Occurrence and deterioration of endophthalmitis during protocol treatment [ Time Frame: 12 weeks and 4 weeks ] [ Designated as safety issue: No ]
Treatment success according to causative species, antifungal susceptibility profile, underlying condition [ Time Frame: 12 weeks and 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	190
Study Start Date:	August 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Fluconazole 400mg/day
2: Active Comparator	Drug: Micafungin 150mg/day

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304772

Contacts

Contact: Shunji Takakura, MD, PhD	+81-75-751-3503	stakakr@kuhp.kyoto-u.ac.jp
Contact: Naoko Fujihara, MD	+81-75-751-4237	fujihara@kuhp.kyoto-u.ac.jp

Locations

Japan
Department of Clinical Laboratory Medicine, Kyoto University Hospital	Recruiting
Kyoto, Japan, 606-8507
Contact: Satoshi Ichiyama, MD, PhD +81-75-751-3502 sichiyam@kuhp.kyoto-u.ac.jp
Contact: Yoshitsugu Iinuma, MD, PhD +81-75-751-3476 yiinuma@kuhp.kyoto-u.ac.jp
Principal Investigator: Shunji Takakura, MD, PhD

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

More Information

Responsible Party:	Kyoto University Hospital ( Shunji Takakura )
Study ID Numbers:	JCRID0502
Study First Received:	March 17, 2006
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00304772
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyoto University:

Candida
bloodstream infection
fluconazole
micafungin
randomized controlled trial

Study placed in the following topic categories:

Fluconazole
Mycoses
Sepsis
Candidiasis
Clotrimazole

Miconazole
Tioconazole
Torulopsis
Micafungin

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antifungal Agents
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009