A Phase 4 interventional study of Fluconazole and Micafungin in Candidiasis and Sepsis, sponsored by Kyoto University. Withdrawn at 1 site in Japan. Per ClinicalTrials.gov, last updated 2024-06-14.
Sponsored by Kyoto University · Phase 4, Interventional, and Treatment
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.
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.
132 studies on the registry are indexed under Candidiasis; 9 are open to participants now.
Browse Candidiasis studies →Kyoto University is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Fluconazole
Drug: Micafungin
400mg/day
150mg/day
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
Safety
Time frame: 12 weeks and 4 weeks
Duration of protocol treatment period in patients with treatment success
Time frame: 12 weeks and 4 weeks
Overall survival at 4 and 12 weeks
Time frame: 12 weeks and 4 weeks
Recurrence in patients who completed protocol treatment
Time frame: 12 weeks and 4 weeks
Occurrence and deterioration of endophthalmitis during protocol treatment
Time frame: 12 weeks and 4 weeks
Treatment success according to causative species, antifungal susceptibility profile, underlying condition
Time frame: 12 weeks and 4 weeks
This study is withdrawn, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Fluconazole · Micafungin
Kyoto University