Invasive CandidiasisPhase 4EPICA1NCT03906916
Comparison of Two Diagnostic Tests in Patients With Suspected Invasive Candidiasis in Internal Medicine Wards and Who Are Currently Timely Treated With Micafungin
A Phase 4 study testing 1,3-β-D-glucan quantification and Micafungin in people with Invasive Candidiasis, run by Fadoi Foundation, Italy at 20 sites in Italy.
Trial summary
EPICA-1 is a multicenter, open label, interventional study which will involve about 30 Internal Medicine Units throughout Italy, enrolling globally at least 100 hospitalised patients with suspicion of invasive candidiasis. 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?
- 1,3-β-D-glucan quantification and Micafungin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 20 sitesItaly
- Study dates
- 18 Jul 2018to 1 Feb 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years
- Patients giving their informed consent to participate to the study and to the use of their health data
- Patients with two or more SIRS criteria (hyperthermia, or hypothermia, tachycardia, tachypnea, leucocytosis or leukopenia )
- Patients treated with antibiotic therapy in the last 4 weeks and with central venous catheter
- Patients with at least one of these conditions ( cortisone therapy/ immunosuppressive agents, total parenteral nutrition, urinary catheter, anticancer chemotherapy and major surgery in the last 3 weeks, acute pancreatitis, diabetes mellitus, liver diseases, dialysis)
Who cannot join
- Patients with ALT, AST, bilirubin > 3 times the upper limit of normal
- Patients enrolled in other interventional clinical studies
- Patients treated with echinocandin or azolic or polyene at the time of the enrolment
- Pregnancy or breastfeeding
- Neutropenic patients
- HIV positive patients
- Central nervous system events
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
Osp. Generale Regionale F. Miulli
Acquaviva delle Fonti
Nuovo Ospedale Civile S. Agostino-Estense
Baggiovara
Ospedale di Bussolengo
Bussolengo
Ospedale "S. Anna"
Castelnovo ne' Monti
ASL CN1 Ospedale di Ceva
Ceva
Ospedale Maggiore
Chieri
Ospedale "S. Anna"
Como
Ospedale "S. Biagio"
Domodossola
Ente Ospedaliero Galliera
Genova
Ospedale "Mater Salutis"
Legnago
Ospedale "S.M. Bianca"
Mirandola
Ospedale di Mondovì,
Mondovì
Ospedale "Antonio Cardarelli
Naples
Presidio Ospedaliero S. Maria Delle Grazie
Pozzuoli
Ospedale "G. Fracastoro"
San Bonifacio
Nuovo Ospedale Civile di Sassuolo
Sassuolo
Ospedale Maggiore SS. Annunziata
Savigliano
Ospedale Civile di Sestri Levante
Sestri Levante
Policlinico Borgo Roma
Verona
Ospedale "Magalini
Villafranca di Verona
About this study
Official title: Multicenter Study to Compare Two Diagnostic Tests (1,3-β-D-glucan vs Blood Culture) in Critically Ill Patients With Suspected Invasive CAndidiasis Hospitalized in Internal Medicine Wards and Who Are Currently Timely Treated With Echinocandin (Micafungin)
EPICA-1 is a multicenter, open label, interventional study which will involve about 30 Internal Medicine Units throughout Italy, enrolling globally at least 100 hospitalised patients with suspicion of invasive candidiasis. These patients will be treated with an echinocandin (micafungin) as timely as possible, and they will continue the antifungal treatment according to international guidelines when diagnosis is confirmed by positive 1,3-β-D-glucan test: this will allow collection of information on patients outcome. At the same time, patients will be also evaluated by means of blood culture, so that comparison will be possible between the two diagnostic tests (primary end-point of the study).
- Conditions
- Invasive Candidiasis
- Being tested
- 1,3-β-D-glucan quantification, Micafungin
- Medical subject headings
- Candidiasis, Invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1,3-β-D-glucan quantificationDiagnostic test
Also called FUNGITELL
Patients hospitalised in Internal Medicine with suspicion of invasive candidiasis will be evaluated by 1,3-β-D-glucan test and by means of blood culture to confirm the diagnosis
MicafunginDrug
Patients hospitalised in Internal Medicine with suspicion of invasive candidiasis will be treated with an echinocandin (micafungin) as timely as possible, and they will continue the antifungal treatment according to international guidelines when diagnosis is confirmed by positive 1,3-β-D-glucan test.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspicion of invasive candidiasis | Experimental | Patients hospitalised in Internal Medicine with suspicion of invasive candidiasis will be treated with an echinocandin (micafungin) as timely as possible, and they will continue the antifungal treatment according to international guidelines when diagnosis is confirmed by positive 1,3-β-D-glucan test. Receives: Diagnostic Test: 1,3-β-D-glucan quantification; Drug: Micafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the equivalence between two diagnostic test for Candida infections: 1,3-β-D-glucan vs. emocoltura
Will be compared the results of the two diagnostic tests for the same patient's blood sample. In particular will be evaluated if there is accordance between the Candida positivity of an emocolture and the positivity of the 1,3-β-D-glucan test (1,3-β-D-glucan concentrations > 200 pg/ml) for the same patient's blood sample.
Measured: 14 days
Secondary outcomes (2)
To assess the effect of a pre-emptive micafungin treatment on the outcome of patients.
Will be evaluated the mortality (number of dead patients) and ICU transfering (number of patients move to the ICU) reductions
Measured: 14 days
To describe the trend of 1,3-β-D-glucan in patients during micafungin treatment
Will be measured the 1,3-β-D-glucan concentrations in in patients during micafungin treatment
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start18 Jul 2018
- Primary completion31 Dec 2018
- Study completion1 Feb 2019
Why it stopped: The study was interrupted prematurely because of the low rate of recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fadoi Foundation, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906916
- Sponsor's protocol ID
- FADOI.02.2017
- Acronym
- EPICA1
- Status last verified
- Apr 2021
- First submitted
- 20 Jul 2018
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study to Compare Two Diagnostic Tests (1,3-β-D-glucan vs Blood Culture) in Critically Ill Patients With Suspected Invasive CAndidiasis Hospitalized in Internal Medicine Wards and Who Are Currently Timely Treated With Echinocandin (Micafungin)
- ClinicalTrials.gov ID
- NCT03906916
- Acronym / sponsor ID
- EPICA1 / FADOI.02.2017
- Conditions
- Invasive Candidiasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was interrupted prematurely because of the low rate of recruitment.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Fadoi Foundation, ItalyUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 8 Apr 2019 (actual)
- 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.
EPICA-1 is a multicenter, open label, interventional study which will involve about 30 Internal Medicine Units throughout Italy, enrolling globally at least 100 hospitalised patients with suspicion of invasive candidiasis. These patients will be treated with an echinocandin (micafungin) as timely as possible, and they will continue the antifungal treatment according to international guidelines when diagnosis is confirmed by positive 1,3-β-D-glucan test: this will allow collection of information on patients outcome. At the same time, patients will be also evaluated by means of blood culture, so that comparison will be possible between the two diagnostic tests (primary end-point of the study).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspicion of invasive candidiasis | Experimental | Diagnostic Test: 1,3-β-D-glucan quantification, Drug: MicafunginPatients hospitalised in Internal Medicine with suspicion of invasive candidiasis will be treated with an echinocandin (micafungin) as timely as possible, and they will continue the antifungal treatment according to international guidelines when diagnosis is confirmed by positive 1,3-β-D-glucan test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years
- Patients giving their informed consent to participate to the study and to the use of their health data
- Patients with two or more SIRS criteria (hyperthermia, or hypothermia, tachycardia, tachypnea, leucocytosis or leukopenia )
- Patients treated with antibiotic therapy in the last 4 weeks and with central venous catheter
- Patients with at least one of these conditions ( cortisone therapy/ immunosuppressive agents, total parenteral nutrition, urinary catheter, anticancer chemotherapy and major surgery in the last 3 weeks, acute pancreatitis, diabetes mellitus, liver diseases, dialysis)
Key exclusion criteria (7 listed)
- Patients with ALT, AST, bilirubin > 3 times the upper limit of normal
- Patients enrolled in other interventional clinical studies
- Patients treated with echinocandin or azolic or polyene at the time of the enrolment
- Pregnancy or breastfeeding
- Neutropenic patients
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 |
|---|---|---|
| 1,3-β-D-glucan quantificationAlso: FUNGITELLPatients hospitalised in Internal Medicine with suspicion of invasive candidiasis will be evaluated by 1,3-β-D-glucan test and by means of blood culture to confirm the diagnosis | Diagnostic test | Patients with suspicion of invasive candidiasis |
| MicafunginPatients hospitalised in Internal Medicine with suspicion of invasive candidiasis will be treated with an echinocandin (micafungin) as timely as possible, and they will continue the antifungal treatment according to international guidelines when diagnosis is confirmed by positive 1,3-β-D-glucan test. | Drug | Patients with suspicion of invasive candidiasis |
Primary outcome
To assess the equivalence between two diagnostic test for Candida infections: 1,3-β-D-glucan vs. emocoltura
Time frame: 14 days
Will be compared the results of the two diagnostic tests for the same patient's blood sample. In particular will be evaluated if there is accordance between the Candida positivity of an emocolture and the positivity of the 1,3-β-D-glucan test (1,3-β-D-glucan concentrations > 200 pg/ml) for the same patient's blood sample.
2 secondary outcomes
To assess the effect of a pre-emptive micafungin treatment on the outcome of patients.
Time frame: 14 days
To describe the trend of 1,3-β-D-glucan in patients during micafungin treatment
Time frame: 14 days
Results and safety
The study was stopped early (reason given: The study was interrupted prematurely because of the low rate of recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
20 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 1,3-β-D-glucan quantification and Micafungin in people with Invasive Candidiasis, run by Fadoi Foundation, Italy at 20 sites in Italy.
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 5 inclusion and 7 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 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. 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 stopped early (reason given: The study was interrupted prematurely because of the low rate of recruitment.). 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?
To assess the equivalence between two diagnostic test for Candida infections: 1,3-β-D-glucan vs. emocoltura (time frame: 14 days). 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 12 Apr 2021.