Aspergillosis/BloodPhase 4NCT00423163
A Study to Evaluate the Effectiveness of Voriconazole + Micafungin Versus Voriconazole Alone for Invasive Aspergillosis
A Phase 4 study testing micafungin and voriconazole in people with Aspergillosis/Blood and Aspergillosis/Invasive, run by Astellas Pharma Inc at 44 sites in United States.
Trial summary
To evaluate the therapeutic effectiveness of voriconazole + micafungin versus voriconazole alone as primary therapy for invasive aspergillosis. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Aspergillosis/Blood, Aspergillosis/Invasive
- What is being tested?
- micafungin and voriconazole
- How many people
- 0 participants
- Where
- 44 sitesUnited States
- Study dates
- Feb 2007to not given
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Proven, probable or possible invasive aspergillosis
- Patient is 2 years of age or older
Who cannot join
- The patient has been administered an antifungal agent (voriconazole, itraconazole, posaconazole, caspofungin, micafungin, anidulafungin, amphotericin B, or lipid formulation of amphotericin B) for >7 days immediately prior to randomization for treatment of the Possible, Probable, or Proven invasive aspergillosis for which the patient is being enrolled.
- The patient has been treated with voriconazole for > 7 days immediately prior to randomization
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Study site
Akron, Ohio
Study site
Albany, New York
Study site
Ann Arbor, Michigan
Study site
Atlanta, Georgia
Study site
Baltimore, Maryland
Study site
Beech Grove, Indiana
Study site
Bethesda, Maryland
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Charlestown, Massachusetts
Study site
Charlottesville, Virginia
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Columbus, Ohio
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Detroit, Michigan
Study site
Fairfax, Virginia
Study site
Fountain Valley, California
Study site
Grand Rapids, Michigan
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Kansas City, Kansas
Study site
Lexington, Kentucky
Study site
Los Angeles, California
Study site
Madison, Wisconsin
Study site
Miami, Florida
Study site
Minneapolis, Minnesota
Study site
New York, New York
Study site
Omaha, Nebraska
Study site
Palo Alto, California
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
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Portland, Oregon
Study site
Richmond, Virginia
Study site
Rochester, Minnesota
Study site
Rochester, New York
Study site
Sacramento, California
Study site
San Antonio, Texas
Study site
San Francisco, California
Study site
Washington D.C., District of Columbia
Study site
Wichita, Kansas
Study site
Winston-Salem, North Carolina
Study site
Worcester, Massachusetts
About this study
Official title: A Double-Blind, Randomized Controlled Trial of Voriconazole (VFEND®) Plus Micafungin (MYCAMINE™) Versus Voriconazole Plus Placebo in the Treatment of Patients With Proven or Probable Invasive Aspergillosis
To evaluate the therapeutic effectiveness of voriconazole + micafungin versus voriconazole alone as primary therapy for invasive aspergillosis.
- Conditions
- Aspergillosis/Blood, Aspergillosis/Invasive
- Being tested
- micafungin, voriconazole
- Keywords
- Aspergillosis/blood, micafungin, voriconazole, Aspergillus
- Medical subject headings
- Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micafunginDrug
voriconazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be Global Success (complete and partial response) at 6 weeks based on the combination of clinical, mycological and radiologic response.
Secondary outcomes (1)
Global Success (GS) at Wk 12, Favorable response (FR) & survival at Wks 6 & 12. GS and FR by infection site, overall frequency of emergent & recurrent fungal infections at Wks 6 & 12, duration of FR, and relationship of galactomannan to clinical outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startFeb 2007
Why it stopped: An alternative joint industry effort will provide information on combination versus single agent therapy for treatment of aspergillosis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspergillosis/BloodStudies 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
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Use Central Contact, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423163
- Sponsor's protocol ID
- 20-05-002
- Status last verified
- Aug 2015
- First submitted
- 17 Jan 2007
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized Controlled Trial of Voriconazole (VFEND®) Plus Micafungin (MYCAMINE™) Versus Voriconazole Plus Placebo in the Treatment of Patients With Proven or Probable Invasive Aspergillosis
- ClinicalTrials.gov ID
- NCT00423163
- Acronym / sponsor ID
- 20-05-002
- Conditions
- Aspergillosis/Blood, Aspergillosis/Invasive
- Keywords
- Aspergillosis/blood, micafungin, voriconazole, Aspergillus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: An alternative joint industry effort will provide information on combination versus single agent therapy for treatment of aspergillosis
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- First posted
- 18 Jan 2007 (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.
To evaluate the therapeutic effectiveness of voriconazole + micafungin versus voriconazole alone as primary therapy for invasive aspergillosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Proven, probable or possible invasive aspergillosis
- Patient is 2 years of age or older
Key exclusion criteria (2 listed)
- The patient has been administered an antifungal agent (voriconazole, itraconazole, posaconazole, caspofungin, micafungin, anidulafungin, amphotericin B, or lipid formulation of amphotericin B) for >7 days immediately prior to randomization for treatment of the Possible, Probable, or Proven invasive aspergillosis for which the patient is being enrolled.
- The patient has been treated with voriconazole for > 7 days immediately prior to randomization
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 |
|---|---|---|
| micafungin | Drug | – |
| voriconazole | Drug | – |
Primary outcome
The primary outcome will be Global Success (complete and partial response) at 6 weeks based on the combination of clinical, mycological and radiologic response.
1 secondary outcome
Global Success (GS) at Wk 12, Favorable response (FR) & survival at Wks 6 & 12. GS and FR by infection site, overall frequency of emergent & recurrent fungal infections at Wks 6 & 12, duration of FR, and relationship of galactomannan to clinical outcome
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 2 Sep 2015.
Related trials for Aspergillosis/Blood
RecruitingObservational study
PCR for Aspergillus Fumigatus in Blood and Bronchoalveolar Lavage Fluid for Monitoring Cases of Invasive Aspergillosis: What is Its Prognostic Value
Invasive Pulmonary Aspergillosis
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.
Use Central Contact study director
Astellas Pharma US, Inc.
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing micafungin and voriconazole in people with Aspergillosis/Blood and Aspergillosis/Invasive, run by Astellas Pharma Inc at 44 sites in United States.
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 2 inclusion and 2 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 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. 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?
The primary outcome will be Global Success (complete and partial response) at 6 weeks based on the combination of clinical, mycological and radiologic response.. 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 2 Sep 2015.