Fluconazole Versus Micafungin for Candida Bloodstream Infection in Non-Neutropenic Patients (NCT00304772) | Clinical Trial Compass
WithdrawnPhase 4
Fluconazole Versus Micafungin for Candida Bloodstream Infection in Non-Neutropenic Patients
Stopped: Subjects were not recruited as intended.
Japan0Started 2006-08
Plain-language 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.
Who can participate
SexALL
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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 dec…
What they're measuring
1
Treatment success (completion of protocol treatment within 12 weeks and recurrence-free survival at 4 weeks after the completion of protocol treatment)