Clinical trial NCT00304772: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Candidiasis
Sepsis
Keywords: Candida
bloodstream infection
fluconazole
micafungin
randomized controlled trial
Lead sponsor: Kyoto University
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Astellas Pharma Inc
First posted: 2006-03-20
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Treatment success (completion of protocol treatment within 12 weeks and recurrence-free survival at 4 weeks after the completion of protocol treatment)
timeFrame: 12 weeks and 4 weeks
Secondary outcomes:
measure: Safety
timeFrame: 12 weeks and 4 weeks
measure: Duration of protocol treatment period in patients with treatment success
timeFrame: 12 weeks and 4 weeks
measure: Overall survival at 4 and 12 weeks
timeFrame: 12 weeks and 4 weeks
measure: Recurrence in patients who completed protocol treatment
timeFrame: 12 weeks and 4 weeks
measure: Occurrence and deterioration of endophthalmitis during protocol treatment
timeFrame: 12 weeks and 4 weeks
measure: Treatment success according to causative species, antifungal susceptibility profile, underlying condition
timeFrame: 12 weeks and 4 weeks
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Department of Clinical Laboratory Medicine, Kyoto University Hospital
Study officials:
affiliation: Professor of Medicine, Department of Clinical Laboratory Medicine, Kyoto University Hospital
name: Satoshi Ichiyama, MD, PhD
role: STUDY_CHAIR
affiliation: Instructor in Medicine, Department of Clinical Laboratory Medicine, Kyoto University Hospital
name: Shunji Takakura, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: