CandidiasisPhase 4NCT00304772
Fluconazole Versus Micafungin for Candida Bloodstream Infection in Non-Neutropenic Patients
A Phase 4 study testing Fluconazole and Micafungin in people with Candidiasis and Sepsis, run by Kyoto University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Candidiasis, Sepsis
- What is being tested?
- Fluconazole and Micafungin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2006to Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Clinical Laboratory Medicine, Kyoto University Hospital
Kyoto, 606-8507
About this study
Official title: A Randomized Comparative Study of Fluconazole Versus Micafungin for the Treatment of Candida Bloodstream Infection in Non-Neutropenic Patients
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.
Read the 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.
- Conditions
- Candidiasis, Sepsis
- Being tested
- Fluconazole, Micafungin
- Keywords
- Candida, bloodstream infection, fluconazole, micafungin, randomized controlled trial
- Medical subject headings
- Candidiasis, Sepsis, Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluconazoleDrug
400mg/day
MicafunginDrug
150mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Fluconazole |
| 2 | Active comparator | Not described Receives: Drug: Micafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success (completion of protocol treatment within 12 weeks and recurrence-free survival at 4 weeks after the completion of protocol treatment)
Measured: 12 weeks and 4 weeks
Secondary outcomes (6)
Safety
Measured: 12 weeks and 4 weeks
Duration of protocol treatment period in patients with treatment success
Measured: 12 weeks and 4 weeks
Overall survival at 4 and 12 weeks
Measured: 12 weeks and 4 weeks
Recurrence in patients who completed protocol treatment
Measured: 12 weeks and 4 weeks
Occurrence and deterioration of endophthalmitis during protocol treatment
Measured: 12 weeks and 4 weeks
Treatment success according to causative species, antifungal susceptibility profile, underlying condition
Measured: 12 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2006 (estimated)
- Study startAug 2006
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Why it stopped: Subjects were not recruited as intended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoto University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Astellas Pharma Inc
- Responsible party
- Principal investigator, Takeshi Morimoto, Kyoto University
- Investigators
- Satoshi Ichiyama, MD, PhD, Study chair, Professor of Medicine, Department of Clinical Laboratory Medicine, Kyoto University HospitalShunji Takakura, MD, PhD, Principal investigator, Instructor in Medicine, Department of Clinical Laboratory Medicine, Kyoto University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304772
- Sponsor's protocol ID
- JCRID0502
- Status last verified
- Jun 2024
- First submitted
- 17 Mar 2006
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Study of Fluconazole Versus Micafungin for the Treatment of Candida Bloodstream Infection in Non-Neutropenic Patients
- ClinicalTrials.gov ID
- NCT00304772
- Acronym / sponsor ID
- JCRID0502
- Conditions
- Candidiasis, Sepsis
- Keywords
- Candida, bloodstream infection, fluconazole, micafungin, randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Subjects were not recruited as intended.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kyoto UniversityUniversity, hospital or other
- Collaborators
- Pfizer, Astellas Pharma Inc
- Study start
- Aug 2006
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 20 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Fluconazole |
| 2 | Active comparator | Drug: Micafungin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluconazole400mg/day | Drug | 1 |
| Micafungin150mg/day | Drug | 2 |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satoshi Ichiyama, MD, PhD study chair
Professor of Medicine, Department of Clinical Laboratory Medicine, Kyoto University Hospital
Shunji Takakura, MD, PhD principal investigator
Instructor in Medicine, Department of Clinical Laboratory Medicine, Kyoto University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluconazole and Micafungin in people with Candidiasis and Sepsis, run by Kyoto University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.