Invasive CandidiasisNCT00672841
β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients
A study testing Preemptive Therapy with Anidulafungin and Empiric antifungal therapy based on physician discretion. in people with Invasive Candidiasis, run by Duke University at 1 site in United States.
Trial summary
This is a single center, prospective, open label assessment of β-D-glucan surveillance with preemptive anidulafungin therapy versus standard care for the prevention of invasive candidiasis in at-risk surgical intensive care unit (SICU) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Candidiasis
- What is being tested?
- Preemptive Therapy with Anidulafungin and Empiric antifungal therapy based on physician discretion.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥18 years
- Admission to the intensive care unit for ≥ 72 hours and expected to stay an additional 48 hours
- IV access for administration of study drug
- Subject (or subject's legal representative) able to give written informed consent
Who cannot join
- History of hypersensitivity or intolerance to echinocandin antifungals
- Liver function test (ALT, AST (aspartate aminotransferase), and/or total bilirubin) greater than 10 times the upper limits of normal (ULN)
- Pregnant or lactating women
- Treatment with systemic antifungal therapy within the preceding 7 days
- Documented invasive fungal infection at baseline/screening
- Life expectancy less than 2 days or moribund
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Randomized Comparison of β-D-Glucan Surveillance With Preemptive Anidulafungin Versus Standard Care for the Management of Invasive Candidiasis in Surgical Intensive Care Unit Patients
This is a single center, prospective, open label assessment of β-D-glucan surveillance with preemptive anidulafungin therapy versus standard care for the prevention of invasive candidiasis in at-risk surgical intensive care unit (SICU) patients. Subjects will be stratified by APACHE II score and randomized in 3:1 fashion to either biweekly surveillance using the β-D-glucan assay or standard care. Subjects in the active monitoring arm will receive intravenous anidulafungin should the β-D-glucan exceed 60 pg/mL on a single determination. Subjects in the standard care arm will have biweekly blood draws for β-D-glucan, but the specimens will be batched and tested retrospectively. Antifungal use in the standard care arm is at the discretion of the treating physicians. The primary study end-points are the feasibility of a preemptive antifungal strategy in a SICU setting, β-D-glucan test characteristics, and the safety and tolerability of preemptive anidulafungin. Risks associated with study participation include the risks associated with blood draws, study drug related side effects, and the potential for loss of confidentiality.
- Conditions
- Invasive Candidiasis
- Being tested
- Preemptive Therapy with Anidulafungin, Empiric antifungal therapy based on physician discretion.
- Keywords
- candidemia, invasive candidiasis, preemptive antifungal therapy, surveillance, β-D-Glucan (BDG)
- Medical subject headings
- Candidiasis, Invasive, Candidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preemptive Therapy with AnidulafunginDrug
Also called Eraxis
Subjects in the active surveillance arm who develop a single positive β-D-glucan test will receive preemptive anidulafungin intravenously. Preemptive therapy will include a loading dose of 200mg followed by 100mg maintenance therapy once a day. The loading and maintenance doses are derived from the FDA cleared schedule for Invasive Candidiasis and candidemia. Preemptive therapy will continue for 14 days.
Empiric antifungal therapy based on physician discretion.Drug
Patients in the standard care group may receive antifungal prophylaxis and/or treatment at any time based on the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Standard care/empiric therapy group Receives: Drug: Empiric antifungal therapy based on physician discretion. |
| 1 | Experimental | Active surveillance/ preemptive therapy group Receives: Drug: Preemptive Therapy with Anidulafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.
Clinical utility was defined as β-D-glucan test performance. Biweekly βDG testing used a threshold of ≥ 60 pg/ml to indicate a positive test for invasive candidiasis. True and false positives, and true and false negatives were confirmed using a composite clinical definition of invasive candidiasis that combines physical symptom/signs and microbiology. Cases of proven/probable invasive fungal infection (IFI) were adjudicated by a single reviewer blinded to group assignment and BDG results.
Measured: Participants were followed until ICU discharge, an average of 17 days
Safety and Tolerability of Preemptive Anidulafungin
reported as the Number of Adverse Events Possibly Related to Study Drug
Measured: weekly until ICU discharge
Secondary outcomes (2)
Validate Gene Expression Signatures Predictive of IC
Measured: Study Completion, an average of 17 days
Incidence of Proven or Probable Invasive Fungal Infection (IFI)
Institution specific criteria were used to establish a diagnosis of proven or probable invasive candidiasis. Other IFIs were classified according to the European Organization for Research and Treatment of Cancer/Mycosis Study Group (EORTC/MSG) criteria. However, BDG results were not factored into the EORTC/MSG criteria.
Measured: Participants were followed until ICU discharge, an average of 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive CandidiasisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Kimberly E Hanson, MD, Principal investigator, UtahBarbara D Alexander, MD, Principal investigator, DukeJohn Perfect, MD, Principal investigator, Duke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672841
- Sponsor's protocol ID
- Pro00003161
- Other IDs
- GA88517X
- Status last verified
- Nov 2012
- First submitted
- 4 May 2008
- Last updated
- 6 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hanson KE, Pfeiffer CD, Lease ED, Balch AH, Zaas AK, Perfect JR, Alexander BD. beta-D-glucan surveillance with preemptive anidulafungin for invasive candidiasis in intensive care unit patients: a randomized pilot study. PLoS One. 2012;7(8):e42282. doi: 10.1371/journal.pone.0042282. Epub 2012 Aug 6.
PubMed 22879929
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of β-D-Glucan Surveillance With Preemptive Anidulafungin Versus Standard Care for the Management of Invasive Candidiasis in Surgical Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT00672841
- Acronym / sponsor ID
- Pro00003161
- Conditions
- Invasive Candidiasis
- Keywords
- candidemia, invasive candidiasis, preemptive antifungal therapy, surveillance, β-D-Glucan (BDG)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 6 May 2008 (estimated)
- Results
- Posted 22 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center, prospective, open label assessment of β-D-glucan surveillance with preemptive anidulafungin therapy versus standard care for the prevention of invasive candidiasis in at-risk surgical intensive care unit (SICU) patients. Subjects will be stratified by APACHE II score and randomized in 3:1 fashion to either biweekly surveillance using the β-D-glucan assay or standard care. Subjects in the active monitoring arm will receive intravenous anidulafungin should the β-D-glucan exceed 60 pg/mL on a single determination. Subjects in the standard care arm will have biweekly blood draws for β-D-glucan, but the specimens will be batched and tested retrospectively. Antifungal use in the standard care arm is at the discretion of the treating physicians. The primary study end-points are the feasibility of a preemptive antifungal strategy in a SICU setting, β-D-glucan test characteristics, and the safety and tolerability of preemptive anidulafungin. Risks associated with study participation include the risks associated with blood draws, study drug related side effects, and the potential for loss of confidentiality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: Empiric antifungal therapy based on physician discretion.Standard care/empiric therapy group |
| 1 | Experimental | Drug: Preemptive Therapy with AnidulafunginActive surveillance/ preemptive therapy group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Admission to the intensive care unit for ≥ 72 hours and expected to stay an additional 48 hours
- IV access for administration of study drug
- Subject (or subject's legal representative) able to give written informed consent
Key exclusion criteria (6 listed)
- History of hypersensitivity or intolerance to echinocandin antifungals
- Liver function test (ALT, AST (aspartate aminotransferase), and/or total bilirubin) greater than 10 times the upper limits of normal (ULN)
- Pregnant or lactating women
- Treatment with systemic antifungal therapy within the preceding 7 days
- Documented invasive fungal infection at baseline/screening
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 |
|---|---|---|
| Preemptive Therapy with AnidulafunginAlso: EraxisSubjects in the active surveillance arm who develop a single positive β-D-glucan test will receive preemptive anidulafungin intravenously. Preemptive therapy will include a loading dose of 200mg followed by 100mg maintenance therapy once a day. The loading and maintenance doses are derived from the FDA cleared schedule for Invasive Candidiasis and candidemia. Preemptive therapy will continue for 14 days. | Drug | 1 |
| Empiric antifungal therapy based on physician discretion.Patients in the standard care group may receive antifungal prophylaxis and/or treatment at any time based on the discretion of the treating physician. | Drug | 2 |
Primary outcome
Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.
Time frame: Participants were followed until ICU discharge, an average of 17 days
Clinical utility was defined as β-D-glucan test performance. Biweekly βDG testing used a threshold of ≥ 60 pg/ml to indicate a positive test for invasive candidiasis. True and false positives, and true and false negatives were confirmed using a composite clinical definition of invasive candidiasis that combines physical symptom/signs and microbiology. Cases of proven/probable invasive fungal infection (IFI) were adjudicated by a single reviewer blinded to group assignment and BDG results.
Safety and Tolerability of Preemptive Anidulafungin
Time frame: weekly until ICU discharge
reported as the Number of Adverse Events Possibly Related to Study Drug
2 secondary outcomes
Validate Gene Expression Signatures Predictive of IC
Time frame: Study Completion, an average of 17 days
Incidence of Proven or Probable Invasive Fungal Infection (IFI)
Time frame: Participants were followed until ICU discharge, an average of 17 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22879929Hanson KE, Pfeiffer CD, Lease ED, Balch AH, Zaas AK, Perfect JR, Alexander BD. beta-D-glucan surveillance with preemptive anidulafungin for invasive candidiasis in intensive care unit patients: a randomized pilot study. PLoS One. 2012;7(8):e42282. doi: 10.1371/journal.pone.0042282. Epub 2012 Aug 6.
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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.
Kimberly E Hanson, MD principal investigator
Utah
Barbara D Alexander, MD principal investigator
Duke
John Perfect, MD principal investigator
Duke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preemptive Therapy with Anidulafungin and Empiric antifungal therapy based on physician discretion. in people with Invasive Candidiasis, run by Duke University at 1 site 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 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: finished, as of the sponsor's last update on 6 Feb 2015. 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients. (time frame: Participants were followed until ICU discharge, an average of 17 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00672841, which also lists 1 linked publication.
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 6 Feb 2015.