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

Condition(s) targeted: Candidiasis; Sepsis

Intervention: Fluconazole (Drug); Micafungin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Kyoto University

Official(s) and/or principal investigator(s):
Satoshi Ichiyama, MD, PhD, Study Chair, Affiliation: Professor of Medicine, Department of Clinical Laboratory Medicine, Kyoto University Hospital
Shunji Takakura, MD, PhD, Principal Investigator, Affiliation: Instructor in Medicine, Department of Clinical Laboratory Medicine, Kyoto University Hospital

Overall contact:
Shunji Takakura, MD, PhD, Phone: +81-75-751-3503, Email: stakakr@kuhp.kyoto-u.ac.jp

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.

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

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

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

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Shunji Takakura, MD, PhD, Phone: +81-75-751-3503, Email: stakakr@kuhp.kyoto-u.ac.jp

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

Starting date: August 2006
Ending date: December 2008
Last updated: June 2, 2008