AspergillosisPhase 2NCT01207128
Trial of Combination Antifungal Therapy (Vori+Mica vs. Vori+Placebo) in Invasive Aspergillosis
A Phase 2 study testing Voriconazole, micafungin in people with Aspergillosis, run by University of Arkansas at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the therapeutic effectiveness of combination antifungal therapy (CAT) of voriconazole plus micafungin versus voriconazole plus placebo equivalent as primary therapy for invasive aspergillosis (IA) in patients with hematological cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspergillosis
- What is being tested?
- Voriconazole, micafungin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to Jan 2012
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient or legally authorized representative has signed an informed consent/assent.
- Assent will be obtained as required by the UAMS IRB.
- The patient has a diagnosis of proven or probable invasive aspergillosis and with positive Aspergillus GM index (≥0.5 ng/ml) provide the patient is not receiving antibiotics, such as piperacillin-tazobactam, that are known to cause false positive GMI
- The patient is 18 years of age or older.
Who cannot join
- The patient is being treated with an unlicensed investigational drug for aspergillosis.
- 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 Probable, or Proven invasive aspergillosis for which the patient is being enrolled.
- Patient has invasive aspergillosis but with negative Aspergillus GM index.
- The patient is pregnant or lactating. If the patient is female and of childbearing potential, the patient must have a negative pregnancy test and avoid becoming pregnant while receiving study drug. A pregnancy test should be performed within 14 days prior to the first dose of study drug.
- The patient has alkaline phosphatase, ALT, AST or total bilirubin greater than five times the upper limit of normal.
- The patient has hepatic cirrhosis.
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- Patients with creatinine > 3 will be enrolled only if able to receive oral voriconazole (specify oral loading dose is 6 mg/kg PO Q 12 hours for 24 hours) then oral maintenance 200 mg PO q 12 hours).
- The patient is on artificial ventilation, and unlikely to be extubated within 24 hours of study entry.
- The patient has a history of allergy, hypersensitivity, or any serious reaction to the azole or echinocandin class of antifungal agents.
- The patient has previously enrolled into this study.
- The patient has a concomitant medical condition, which in the opinion of the Investigator may create an unacceptable additional risk.
- The patient has an active microbiologically-documented deep infection due to a non-Aspergillus mold.
- The patient has a life expectancy of less than seven days.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UAMS
Little Rock, Arkansas, 72205
University of Arkansas
Little Rock, Arkansas, 72205
About this study
Official title: A Phase II Randomized, Double Blind, Placebo-controlled, Trial of Combination Antifungal Therapy (Voriconazole Plus Micafungin vs. Voriconazole Plus Placebo Equivalent) in the Treatment of Invasive Aspergillosis (IA) in Patients With Hematological Cancer
The purpose of this study is to evaluate the therapeutic effectiveness of combination antifungal therapy (CAT) of voriconazole plus micafungin versus voriconazole plus placebo equivalent as primary therapy for invasive aspergillosis (IA) in patients with hematological cancer.
Read the detailed description
Patients will receive either IV micafungin 100 mg or placebo equivalent daily. Intravenous (IV)Voriconazole will be administered at a loading dose of 6 mg/kg every 12 hours for the first 24 hours followed by a maintenance dose of 4 mg/kg every 12 hours. Patients may be switched to oral voriconazole 200 mg BID provided aspergillosis response is achieved and gastrointestinal functions are intact.
- Conditions
- Aspergillosis
- Being tested
- Voriconazole, micafungin
- Medical subject headings
- Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voriconazole, micafunginDrug
Patients will receive either IV micafungin 100 mg or placebo equivalent daily. Intravenous (IV)Voriconazole will be administered at a loading dose of 6 mg/kg every 12 hours for the first 24 hours followed by a maintenance dose of 4 mg/kg every 12 hours. Patients may be switched to oral voriconazole 200 mg BID provided aspergillosis response is achieved and gastrointestinal functions are intact.
| Study group | Role | What they receive |
|---|---|---|
| Voriconazole, Micafungin | Active comparator | Patients will receive either IV micafungin 100 mg or placebo equivalent daily. Intravenous (IV) Voriconazole will be administered at a loading dose of 6 mg/kg every 12 hours for the first 24 hours followed by a maintenance dose of 4 mg/kg every 12 hours. Patients may be switched to oral voriconazole 200 mg BID provided aspergillosis response is achieved and gastrointestinal functions are intact. Receives: Drug: Voriconazole, micafungin |
| Voriconazole+Micafungin or Voriconazole+Placebo | No intervention | Voriconazole+Micafungin or Voriconazole+Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Response is defined as normalization of the serum Aspergillus galactomannan index (GMI)values (first normal GMI value is considered day of response).
Measured: maximum 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startFeb 2011
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: None enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AspergillosisStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elias Anaissie, MD, Study chair, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207128
- Sponsor's protocol ID
- UARK 2010-14
- Status last verified
- Apr 2012
- First submitted
- 21 Sep 2010
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double Blind, Placebo-controlled, Trial of Combination Antifungal Therapy (Voriconazole Plus Micafungin vs. Voriconazole Plus Placebo Equivalent) in the Treatment of Invasive Aspergillosis (IA) in Patients With Hematological Cancer
- ClinicalTrials.gov ID
- NCT01207128
- Acronym / sponsor ID
- UARK 2010-14
- Conditions
- Aspergillosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: None enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 Sep 2010 (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 evaluate the therapeutic effectiveness of combination antifungal therapy (CAT) of voriconazole plus micafungin versus voriconazole plus placebo equivalent as primary therapy for invasive aspergillosis (IA) in patients with hematological cancer.
Detailed description
Patients will receive either IV micafungin 100 mg or placebo equivalent daily. Intravenous (IV)Voriconazole will be administered at a loading dose of 6 mg/kg every 12 hours for the first 24 hours followed by a maintenance dose of 4 mg/kg every 12 hours. Patients may be switched to oral voriconazole 200 mg BID provided aspergillosis response is achieved and gastrointestinal functions are intact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Voriconazole, Micafungin | Active comparator | Drug: Voriconazole, micafunginPatients will receive either IV micafungin 100 mg or placebo equivalent daily. Intravenous (IV) Voriconazole will be administered at a loading dose of 6 mg/kg every 12 hours for the first 24 hours followed by a maintenance dose of 4 mg/kg every 12 hours. Patients may be switched to oral voriconazole 200 mg BID provided aspergillosis response is achieved and gastrointestinal functions are intact. |
| Voriconazole+Micafungin or Voriconazole+Placebo | No intervention | –Voriconazole+Micafungin or Voriconazole+Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient or legally authorized representative has signed an informed consent/assent.
- Assent will be obtained as required by the UAMS IRB.
- The patient has a diagnosis of proven or probable invasive aspergillosis and with positive Aspergillus GM index (≥0.5 ng/ml) provide the patient is not receiving antibiotics, such as piperacillin-tazobactam, that are known to cause false positive GMI
- The patient is 18 years of age or older.
Key exclusion criteria (13 listed)
- The patient is being treated with an unlicensed investigational drug for aspergillosis.
- 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 Probable, or Proven invasive aspergillosis for which the patient is being enrolled.
- Patient has invasive aspergillosis but with negative Aspergillus GM index.
- The patient is pregnant or lactating. If the patient is female and of childbearing potential, the patient must have a negative pregnancy test and avoid becoming pregnant while receiving study drug. A pregnancy test should be performed within 14 days prior to the first dose of study drug.
- The patient has alkaline phosphatase, ALT, AST or total bilirubin greater than five times the upper limit of normal.
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 |
|---|---|---|
| Voriconazole, micafunginPatients will receive either IV micafungin 100 mg or placebo equivalent daily. Intravenous (IV)Voriconazole will be administered at a loading dose of 6 mg/kg every 12 hours for the first 24 hours followed by a maintenance dose of 4 mg/kg every 12 hours. Patients may be switched to oral voriconazole 200 mg BID provided aspergillosis response is achieved and gastrointestinal functions are intact. | Drug | Voriconazole, Micafungin |
Primary outcome
Response
Time frame: maximum 6 weeks
Response is defined as normalization of the serum Aspergillus galactomannan index (GMI)values (first normal GMI value is considered day of response).
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 20 Apr 2012.
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A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis
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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.
Elias Anaissie, MD study chair
University of Arkansas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Voriconazole, micafungin in people with Aspergillosis, run by University of Arkansas at 2 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 4 inclusion and 13 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 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Response (time frame: maximum 6 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 20 Apr 2012.