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This study has been withdrawn prior to enrollment.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:
Kyoto University
Collaborators:
Pfizer
Astellas Pharma Inc
Information provided by:
Kyoto University
ClinicalTrials.gov Identifier:
NCT00304772
First received: March 17, 2006
Last updated: March 24, 2009
Last verified: March 2009
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety [ Time Frame: 12 weeks and 4 weeks ] [ Designated as safety issue: Yes ]
- Duration of protocol treatment period in patients with treatment success [ Time Frame: 12 weeks and 4 weeks ] [ Designated as safety issue: No ]
- Overall survival at 4 and 12 weeks [ Time Frame: 12 weeks and 4 weeks ] [ Designated as safety issue: No ]
- Recurrence in patients who completed protocol treatment [ Time Frame: 12 weeks and 4 weeks ] [ Designated as safety issue: No ]
- Occurrence and deterioration of endophthalmitis during protocol treatment [ Time Frame: 12 weeks and 4 weeks ] [ Designated as safety issue: No ]
- Treatment success according to causative species, antifungal susceptibility profile, underlying condition [ Time Frame: 12 weeks and 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 190 |
| 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| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Shunji Takakura, Kyoto University Hospital |
| ClinicalTrials.gov Identifier: | NCT00304772 History of Changes |
| Other Study ID Numbers: | JCRID0502 |
| Study First Received: | March 17, 2006 |
| Last Updated: | March 24, 2009 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Kyoto University:
|
Candida bloodstream infection fluconazole micafungin randomized controlled trial |
Additional relevant MeSH terms:
|
Candidiasis Sepsis Mycoses Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Fluconazole |
Micafungin Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013