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

This study has been withdrawn prior to enrollment.
(Subjects were not recruited as intended.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00304772
First Posted: March 20, 2006
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Pfizer
Astellas Pharma Inc
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University
  Purpose
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.

Condition Intervention Phase
Candidiasis Sepsis Drug: Fluconazole Drug: Micafungin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparative Study of Fluconazole Versus Micafungin for the Treatment of Candida Bloodstream Infection in Non-Neutropenic Patients

Resource links provided by NLM:


Further study details as provided by Takeshi Morimoto, Kyoto University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: August 2006
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Fluconazole
400mg/day
Active Comparator: 2 Drug: Micafungin
150mg/day

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304772


Locations
Japan
Department of Clinical Laboratory Medicine, Kyoto University Hospital
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Kyoto University
Pfizer
Astellas Pharma Inc
Investigators
Study Chair: Satoshi Ichiyama, MD, PhD Professor of Medicine, Department of Clinical Laboratory Medicine, Kyoto University Hospital
Principal Investigator: Shunji Takakura, MD, PhD Instructor in Medicine, Department of Clinical Laboratory Medicine, Kyoto University Hospital
  More Information

Responsible Party: Takeshi Morimoto, Professor of Medicine, Kyoto University
ClinicalTrials.gov Identifier: NCT00304772     History of Changes
Other Study ID Numbers: JCRID0502
First Submitted: March 17, 2006
First Posted: March 20, 2006
Last Update Posted: March 15, 2017
Last Verified: March 2017

Keywords provided by Takeshi Morimoto, Kyoto University:
Candida
bloodstream infection
fluconazole
micafungin
randomized controlled trial

Additional relevant MeSH terms:
Infection
Candidiasis
Mycoses
Fluconazole
Micafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors