CandidemiaAntiCandiTreatNCT03799172
Echinocandins Versus Azoles for Candidemia Treatment
An observational study of Candidemia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Candidemia is the most frequent invasive fungal disease in intensive care units (ICUs). It remains a major health concern, considering its attributable mortality up to 40% in critically ill patients. Successful clinical outcome requires early diagnosis and effective antifungal therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Candidemia
- What is being tested?
- Echinocandin treatment and Triazole treatment
- How many people
- 79 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2018to 1 Sep 2019
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a diagnosis of candidemia during their ICU stay
Who may be able to join
- Patients who had a diagnosis of candidemia during ICU stay and were treated with echinocandins or azoles
Who cannot join
- Patients with neutropenia
- Patients without antifungal treatment
- Patients who received antifungal therapy for more than two days before candidemia diagnosis
- Patients receiving liposomal amphotericin b or multiple antifungal agents as first-line therapy
- Patients who received less than 4 days of antifungal therapy after candidemia diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Echinocandins Versus Azoles as First-line Therapy for the Treatment of Candidemia in Intensive Care Units
Candidemia is the most frequent invasive fungal disease in intensive care units (ICUs). It remains a major health concern, considering its attributable mortality up to 40% in critically ill patients. Successful clinical outcome requires early diagnosis and effective antifungal therapy. Guidelines for the treatment of candidemia were published by the Infectious Diseases Society of America (IDSA) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). According to these guidelines, echinocandins are the preferred first-line therapy for candidemia in critically ill patients. Considering the bibliography supporting this statement, the place of triazoles still needs to be defined in candidemia therapeutic arsenal. In this context, we are setting up a retrospective cohort study using Hospital database to compare the efficacy of echinocandins and azoles for the treatment of candidemia in intensive care units.
- Conditions
- Candidemia
- Being tested
- Echinocandin treatment, Triazole treatment
- Medical subject headings
- Candidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echinocandin treatmentDrug
Patients received echinocandins as a first-line therapy after candidemia diagnosis according to the standard of care
Triazole treatmentDrug
Patients received triazoles as a first-line therapy after candidemia diagnosis according to the standard of care.
Candidemia was defined as at least one blood culture positive for Candida.
| Study group | Role | What they receive |
|---|---|---|
| Echinocandin group | Echinocandin group is the group of patients who received echinocandins as first-line therapy for candidemia Receives: Drug: Echinocandin treatment | |
| Triazole group | Triazole group is the group of patients who received triazoles as first-line therapy for candidemia Receives: Drug: Triazole treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of all cause hospital mortality on day 90 between echinocandins and azoles
Comparison of all cause hospital mortality on day 90 between echinocandins and azoles
Measured: Mortality on day 90 after antifungal initiation
Secondary outcomes (1)
Comparison of treatment success on day 30 between echinocandins and azoles.
Treatment success is defined as a complete response if the following two criteria were full-filled: survival and resolution of all attributable symptoms and signs of disease, and mycological success (documented clearance of pathogen from the blood).
Measured: Treatment success on day 30 after antifungal initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start1 Nov 2018
- Primary completion1 Feb 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CandidemiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799172
- Sponsor's protocol ID
- CRC_GHN_2019_001
- Acronym
- AntiCandiTreat
- Status last verified
- Mar 2020
- First submitted
- 3 Jan 2019
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echinocandins Versus Azoles as First-line Therapy for the Treatment of Candidemia in Intensive Care Units
- ClinicalTrials.gov ID
- NCT03799172
- Acronym / sponsor ID
- AntiCandiTreat / CRC_GHN_2019_001
- Conditions
- Candidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 10 Jan 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.
Candidemia is the most frequent invasive fungal disease in intensive care units (ICUs). It remains a major health concern, considering its attributable mortality up to 40% in critically ill patients. Successful clinical outcome requires early diagnosis and effective antifungal therapy. Guidelines for the treatment of candidemia were published by the Infectious Diseases Society of America (IDSA) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). According to these guidelines, echinocandins are the preferred first-line therapy for candidemia in critically ill patients. Considering the bibliography supporting this statement, the place of triazoles still needs to be defined in candidemia therapeutic arsenal. In this context, we are setting up a retrospective cohort study using Hospital database to compare the efficacy of echinocandins and azoles for the treatment of candidemia in intensive care units.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echinocandin group | – | Drug: Echinocandin treatmentEchinocandin group is the group of patients who received echinocandins as first-line therapy for candidemia |
| Triazole group | – | Drug: Triazole treatmentTriazole group is the group of patients who received triazoles as first-line therapy for candidemia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a diagnosis of candidemia during their ICU stay
Key inclusion criteria (1 listed)
- Patients who had a diagnosis of candidemia during ICU stay and were treated with echinocandins or azoles
Key exclusion criteria (5 listed)
- Patients with neutropenia
- Patients without antifungal treatment
- Patients who received antifungal therapy for more than two days before candidemia diagnosis
- Patients receiving liposomal amphotericin b or multiple antifungal agents as first-line therapy
- Patients who received less than 4 days of antifungal therapy after candidemia diagnosis
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 |
|---|---|---|
| Echinocandin treatmentPatients received echinocandins as a first-line therapy after candidemia diagnosis according to the standard of care | Drug | Echinocandin group |
| Triazole treatmentPatients received triazoles as a first-line therapy after candidemia diagnosis according to the standard of care. Candidemia was defined as at least one blood culture positive for Candida. | Drug | Triazole group |
Primary outcome
Comparison of all cause hospital mortality on day 90 between echinocandins and azoles
Time frame: Mortality on day 90 after antifungal initiation
Comparison of all cause hospital mortality on day 90 between echinocandins and azoles
1 secondary outcome
Comparison of treatment success on day 30 between echinocandins and azoles.
Time frame: Treatment success on day 30 after antifungal initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: Undecided
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A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
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Candidemia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Candidemia, run by Hospices Civils de Lyon at 1 site in France.
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 1 inclusion and 5 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 4 Mar 2020. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of all cause hospital mortality on day 90 between echinocandins and azoles (time frame: Mortality on day 90 after antifungal initiation). 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 4 Mar 2020.