CandidemiaPhase 4NCT01734525
Negative Beta Glucan in ICU Patients
A Phase 4 study testing Anidulafungin in people with Candidemia, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
This is a prospective study aimed at testing a strategy of early initiation of an antifungal agent to patients admitted to intensive care units (ICUs) at risk for invasive candidiasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidemia
- What is being tested?
- Anidulafungin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2012to Dec 2013
- Phase
- Phase 4
- 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
- In the ICU for >2 days AND
- Systemic antibiotics on days 1-3 of ICU OR
- Central venous catheter on days 1-3 of ICU
- AND at least 2 of:
- Total parenteral nutrition on days 1-3 of ICU
- Any dialysis on days 1-3 of ICU
Show all 16Show fewer
- Major surgery in the 7 days before admission in the ICU
- Pancreatitis in the 7 days before admission in the ICU
- Use of corticosteroids for at least 3 days in the 7 days before admission
- Use of other immunosuppressive agents in the 7 days before admission in the ICU
- In addition, the patient must have at least one of the following:
- Fever (axillary temperature >37.5 oC)
- Hypothermia (axillary temperature <35 oC)
- Hypotension
- Unexplained acidosis
- Unexplained elevation in C-reactive protein
Who cannot join
- Antifungal for >3 days
- Allergy to an echinocandin
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 21941913
About this study
Official title: A Pilot Study for the Use of Biomarkers and Early Treatment of Invasive Candidiasis in ICU Patients
This is a prospective study aimed at testing a strategy of early initiation of an antifungal agent to patients admitted to intensive care units (ICUs) at risk for invasive candidiasis. Score system have been developed to identify groups at very high risk for the development of candidemia/invasive candidiasis in the ICU. These scoring system have used clinical information with or without data on Candida colonization, and have shown reasonable correlation with candidemia/invasive candidiasis. More recently, a biomarker - detection of 1,3-beta-D-glucan in the serum - has been tested in the early diagnosis of candidiasis. The incorporation of biomarkers such as beta-D-glucan could help clinicians to select a group at higher risk for candidemia, and despite the fact that these tests may give false-positive results, their negative predictive value could be of great help.
Therefore, the objectives of this study are:
- To assess the frequency of positive biomarkers in ICU patients at high risk to develop invasive candidiasis/candidemia;
- To test the strategy of early discontinuation of antifungal therapy based on repeatedly negative blood cultures and 1,3 beta-D-glucan in the serum.
Read the detailed description
Entry criteria are: In the ICU for >2 days AND systemic antibiotics >2 days OR central venous catheter for >days AND at least two of the following: total parenteral nutrition, dialysis, surgery, pancreatitis, receipt of corticosteroids, receipt of other immunosuppressive agents. In addition, patients must have a clinical sign of infection (either one of the following): fever, hypothermia, hypotension, unexplained acidosis, or unexplained elevation in C-reactive protein.
Eligible patients will be enrolled after signing an informed consent and will have blood obtained for culture and determination of 1,3 beta-D-glucan serum levels for 3 days, and will start anidulafungin IV.
If all tests are negative, anidulafungin will be discontinued on day 4. If 1,3 beta-D-glucan is positive (>80 pg/ml) and / or blood cultures are positive for Candida species, anidulafungin will be continued for >14 days.
- Conditions
- Candidemia
- Being tested
- Anidulafungin
- Keywords
- candidemia, intensive care unit, 1,3 beta-D-glucan
- Medical subject headings
- Candidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnidulafunginDrug
Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards
| Study group | Role | What they receive |
|---|---|---|
| Anidulafungin | Experimental | Patients at risk will receive therapy with anidulafungin Receives: Drug: Anidulafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin
The main interest is to evaluate the ocurrence of candidemia in patients with negative 1,3 beta-D-glucan who discontinue anidulafungin
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionDec 2013
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 CandidemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcio Nucci, Universidade Federal do Rio de Janeiro
- Investigators
- Marcio Nucci, MD, Study chair, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734525
- Sponsor's protocol ID
- Early Therapy
- Status last verified
- Apr 2019
- First submitted
- 20 Nov 2012
- Last updated
- 8 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Nucci M, Nouer SA, Esteves P, Guimaraes T, Breda G, de Miranda BG, Queiroz-Telles F, Colombo AL. Discontinuation of empirical antifungal therapy in ICU patients using 1,3-beta-d-glucan. J Antimicrob Chemother. 2016 Sep;71(9):2628-33. doi: 10.1093/jac/dkw188. Epub 2016 Jun 10.
PubMed 27287231
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for the Use of Biomarkers and Early Treatment of Invasive Candidiasis in ICU Patients
- ClinicalTrials.gov ID
- NCT01734525
- Acronym / sponsor ID
- Early Therapy
- Conditions
- Candidemia
- Keywords
- candidemia, intensive care unit, 1,3 beta-D-glucan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Posted 8 Jul 2019
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 prospective study aimed at testing a strategy of early initiation of an antifungal agent to patients admitted to intensive care units (ICUs) at risk for invasive candidiasis. Score system have been developed to identify groups at very high risk for the development of candidemia/invasive candidiasis in the ICU. These scoring system have used clinical information with or without data on Candida colonization, and have shown reasonable correlation with candidemia/invasive candidiasis. More recently, a biomarker - detection of 1,3-beta-D-glucan in the serum - has been tested in the early diagnosis of candidiasis. The incorporation of biomarkers such as beta-D-glucan could help clinicians to select a group at higher risk for candidemia, and despite the fact that these tests may give false-positive results, their negative predictive value could be of great help.
Therefore, the objectives of this study are:
- To assess the frequency of positive biomarkers in ICU patients at high risk to develop invasive candidiasis/candidemia;
- To test the strategy of early discontinuation of antifungal therapy based on repeatedly negative blood cultures and 1,3 beta-D-glucan in the serum.
Detailed description
Entry criteria are: In the ICU for >2 days AND systemic antibiotics >2 days OR central venous catheter for >days AND at least two of the following: total parenteral nutrition, dialysis, surgery, pancreatitis, receipt of corticosteroids, receipt of other immunosuppressive agents. In addition, patients must have a clinical sign of infection (either one of the following): fever, hypothermia, hypotension, unexplained acidosis, or unexplained elevation in C-reactive protein.
Eligible patients will be enrolled after signing an informed consent and will have blood obtained for culture and determination of 1,3 beta-D-glucan serum levels for 3 days, and will start anidulafungin IV.
If all tests are negative, anidulafungin will be discontinued on day 4. If 1,3 beta-D-glucan is positive (>80 pg/ml) and / or blood cultures are positive for Candida species, anidulafungin will be continued for >14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anidulafungin | Experimental | Drug: AnidulafunginPatients at risk will receive therapy with anidulafungin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- In the ICU for >2 days AND
- AND at least 2 of:
- In addition, the patient must have at least one of the following:
Key exclusion criteria (2 listed)
- Antifungal for >3 days
- Allergy to an echinocandin
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 |
|---|---|---|
| AnidulafunginAnidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards | Drug | Anidulafungin |
Primary outcome
Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin
Time frame: 30 days
The main interest is to evaluate the ocurrence of candidemia in patients with negative 1,3 beta-D-glucan who discontinue anidulafungin
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27287231Nucci M, Nouer SA, Esteves P, Guimaraes T, Breda G, de Miranda BG, Queiroz-Telles F, Colombo AL. Discontinuation of empirical antifungal therapy in ICU patients using 1,3-beta-d-glucan. J Antimicrob Chemother. 2016 Sep;71(9):2628-33. doi: 10.1093/jac/dkw188. Epub 2016 Jun 10.
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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.
Marcio Nucci, MD study chair
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anidulafungin in people with Candidemia, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
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 16 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: finished, as of the sponsor's last update on 8 Jul 2019. 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 Brazil. 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?
Yes. Results are posted in the registry (first posted 8 Jul 2019). 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?
Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin (time frame: 30 days). 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 NCT01734525, 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 8 Jul 2019.