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

NCT00304772

WithdrawnPhase 4

Sponsor: Kyoto University

Conditions: Candidiasis, Sepsis

Interventions: Fluconazole, Micafungin

Countries: Japan

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.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (1)
  • Kyoto, Japan