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

NCT00304772 | Withdrawn Phase 4

• 1 other identifier: JCRID0502
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Candidiasis; Sepsis

Keywords

Candida; bloodstream infection; fluconazole; micafungin; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Treatment success (completion of protocol treatment within 12 weeks and recurrence-free survival at 4 weeks after the completion of protocol treatment)

  12 weeks and 4 weeks

Secondary Outcomes (6)

• Safety

  12 weeks and 4 weeks

• Duration of protocol treatment period in patients with treatment success

  12 weeks and 4 weeks

• Overall survival at 4 and 12 weeks

  12 weeks and 4 weeks

• Recurrence in patients who completed protocol treatment

  12 weeks and 4 weeks

• Occurrence and deterioration of endophthalmitis during protocol treatment

  12 weeks and 4 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Fluconazole

2

ACTIVE COMPARATOR

Drug: Micafungin

Interventions

Fluconazole DRUG

400mg/day

1

Micafungin DRUG

150mg/day

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyoto University: lead
• Pfizer: collaborator
• Astellas Pharma Inc: collaborator

Study Sites (1)

Department of Clinical Laboratory Medicine, Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

MeSH Terms

Conditions

Candidiasis; Sepsis; Torulopsis

Interventions

Fluconazole; Micafungin

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Satoshi Ichiyama, MD, PhD

  Professor of Medicine, Department of Clinical Laboratory Medicine, Kyoto University Hospital

  STUDY CHAIR

• Shunji Takakura, MD, PhD

  Instructor in Medicine, Department of Clinical Laboratory Medicine, Kyoto University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 17, 2006
• First Posted: March 20, 2006
• Study Start: August 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

JP (1)