Invasive Fungal InfectionsPhase 3NCT00048750
Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU
A Phase 3 study testing Micafungin in people with Invasive Fungal Infections, run by Astellas Pharma Inc at 48 sites in 2 countries.
Trial summary
The purpose of this study is to determine the efficacy and safety of intravenous micafungin versus placebo as prophylactic therapy for invasive fungal infections in patients in the intensive care unit considered to be at high risk. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Invasive Fungal Infections
- What is being tested?
- Micafungin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 48 sitesin 2 countries
- Study dates
- Jan 2003to Jun 2003
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Meets entry criteria for high risk
Who cannot join
- Evidence of active invasive fungal infection
- Received more than one dose of systemic antifungal agent within 72 hours prior to first dose of study drug
- Known to be HIV positive who have CD4 count less than 500 cells/mm3
- Has life-expectancy of less than 72 hours or moribund
Trial locations and contacts
48 sites in 2 countries.
48 sites in 2 countries
United States41 sites
Study site
Atlanta, Georgia, 30303
Study site
Baltimore, Maryland, 21201
Study site
Baltimore, Maryland, 21287
Study site
Birmingham, Alabama, 35294
Study site
Boston, Massachusetts, 02114
Study site
Charlottesville, Virginia, 22906
Study site
Cincinnati, Ohio, 45267
Study site
Dallas, Texas, 75246
Study site
Denver, Colorado, 80262
Study site
Detroit, Michigan, 48201
Study site
Durham, North Carolina, 27110
Study site
Durham, North Carolina, 27710
Study site
Hershey, Pennsylvania, 17033
Study site
Indianapolis, Indiana, 46202
Study site
Indianapolis, Indiana, 46260
Study site
Indianapolis, Indiana, 46390
Study site
Little Rock, Arkansas, 72205
Study site
Los Angeles, California, 90033
Study site
Los Angeles, California, 90048
Study site
Maywood, Illinois, 60153
Study site
Minneapolis, Minnesota, 55455
Study site
Nashville, Tennessee, 37212
Study site
Newark, New Jersey, 07103
Study site
Oakland, California, 94609
Study site
Omaha, Nebraska, 68198
Study site
Orange, California, 92868
Study site
Philadelphia, Pennsylvania, 19104
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Portland, Maine, 04102
Study site
Rochester, New York, 14642
Study site
Sacramento, California, 95817
Study site
Salt Lake City, Utah, 84132
Study site
San Antonio, Texas, 78229
Study site
San Francisco, California, 94110
Study site
Santa Barbara, California, 93102
Study site
Seattle, Washington, 98104
Study site
St Louis, Missouri, 63110
Study site
Stanford, California, 94304
Study site
Stanford, California, 94305
Study site
Tampa, Florida, 33601
Study site
Washington D.C., District of Columbia, 20010
Canada7 sites
Study site
Greenfield Park, Quebec, J4V 2H1
Study site
Hamilton, Ontario, L8V 1C3
Study site
London, Ontario, N6A 5A5
Study site
Montreal, Quebec, H3A 1A1
Study site
Ottawa, Ontario, K1H 8L6
Study site
Regina, Saskatchewan, S4P 0W5
Study site
Saskatoon, Saskatchewan, S7N0W8
About this study
Official title: A Phase 3, Randomized,Double-Blind, Comparative Study of Micafungin (FK463) Versus Placebo as Preemptive Prophylactic Antifungal Therapy in Patients in the Intensive Care Unit
The purpose of this study is to determine the efficacy and safety of intravenous micafungin versus placebo as prophylactic therapy for invasive fungal infections in patients in the intensive care unit considered to be at high risk.
- Conditions
- Invasive Fungal Infections
- Being tested
- Micafungin, Placebo
- Keywords
- Anti-Fungal Therapy, Preemptive Anti-Fungal Therapy, Invasive Fungal Infection, Micafungin, ICU
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicafunginDrug
Also called Mycamine, FK463
IV
PlaceboDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Micafungin |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the incidence of a proven or probable invasive fungal infection, catheter tip fungal infection, or deep incisional surgical site infection during the study
Measured: Baseline through one week post-treatment
Secondary outcomes (1)
Assessment of the incidence of patients requiring alternative systemic antifungal therapy to treat suspected infection
Measured: Baseline through one week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2002 (estimated)
- Study startJan 2003
- Primary completionJun 2003
- Study completionJun 2003
Why it stopped: Inadequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal InfectionsStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Central Contact, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048750
- Sponsor's protocol ID
- 01-0-124
- Status last verified
- Mar 2008
- First submitted
- 6 Nov 2002
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized,Double-Blind, Comparative Study of Micafungin (FK463) Versus Placebo as Preemptive Prophylactic Antifungal Therapy in Patients in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT00048750
- Acronym / sponsor ID
- 01-0-124
- Conditions
- Invasive Fungal Infections
- Keywords
- Anti-Fungal Therapy, Preemptive Anti-Fungal Therapy, Invasive Fungal Infection, Micafungin, ICU
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate enrollment
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 8 Nov 2002 (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 determine the efficacy and safety of intravenous micafungin versus placebo as prophylactic therapy for invasive fungal infections in patients in the intensive care unit considered to be at high risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Micafungin |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Meets entry criteria for high risk
Key exclusion criteria (4 listed)
- Evidence of active invasive fungal infection
- Received more than one dose of systemic antifungal agent within 72 hours prior to first dose of study drug
- Known to be HIV positive who have CD4 count less than 500 cells/mm3
- Has life-expectancy of less than 72 hours or moribund
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 |
|---|---|---|
| MicafunginAlso: Mycamine, FK463IV | Drug | 1 |
| PlaceboIV | Drug | 2 |
Primary outcome
Assessment of the incidence of a proven or probable invasive fungal infection, catheter tip fungal infection, or deep incisional surgical site infection during the study
Time frame: Baseline through one week post-treatment
1 secondary outcome
Assessment of the incidence of patients requiring alternative systemic antifungal therapy to treat suspected infection
Time frame: Baseline through one week post-treatment
Results and safety
The study was stopped early (reason given: Inadequate enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
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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.
Central Contact study director
Astellas Pharma US, Inc.
48 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Micafungin in people with Invasive Fungal Infections, run by Astellas Pharma Inc at 48 sites in 2 countries.
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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 stopped early (reason given: Inadequate enrollment). Results are not available in the source record.
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?
Assessment of the incidence of a proven or probable invasive fungal infection, catheter tip fungal infection, or deep incisional surgical site infection during the study (time frame: Baseline through one week post-treatment). 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 27 Mar 2012.