Invasive Candidiasis; Treatment With EchinocandinEMPIRICANDNCT02333448
Evaluate the Performance of Genetic Amplification by Polymerase Chain Reaction (PCR) and the "Mannan Antigenemia and Antimannan Antibodies Couple as a Means of Diagnosis and a Marker of Follow-up in Invasive Candidiasis.
An observational study of Invasive Candidiasis; Treatment With Echinocandin, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The study consists in taking 4 tubes of blood at different times over a period of 10 days, via a catheter (central venous or arterial catheter) already in place in the usual therapeutic management. These samples will make it possible to measure blood levels of certain markers specific to invasive candidiasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Candidiasis; Treatment With Echinocandin
- What is being tested?
- Blood sample taken on the day the treatment is initiated, Blood sample taken on day 3 after initiation of treatment and Blood sample taken on day 5 after initiation of
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2015to 17 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients in a medical Intensive Care Patients with suspected invasive candidiasis
Who may be able to join
- Patient informed about the study
- Patients aged at least 18 years admitted to a medical Intensive Care or general intensive care
- Patients with suspected invasive candidiasis - that is to say:
- Presenting persistent sepsis despite broad-spectrum antibiotherapy for at least 48 hours or targeted antibiotherapy for a documented bacterial infection (sepsis will be defined according to:
- the usual SIRS criteria, at least 2 of the following 4: temperature > 38°C or < 36°C, tachycardia > 90/min, respiratory rate > 20/min or blood pressure carbon dioxide (PaCO2 ) < 32 mmHg, leukocytosis > 12000/mm3 or < 4000/mm3 or > 10% of immature forms.
- Persistent hemodynamic instability (impossibility to significantly diminish catecholamine requirement, need for rapid vascular resuscitation > 1000 ml over the previous 24 hours)
- Candida score ≥ 3 with multifocal colonization
- Decision to initiate echinocandin therapy made by the clinician in charge of the patient
Who cannot join
- Treatment with echinocandin > 1 day in the week preceding inclusion
- Patients not covered by national health insurance
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Value of PCR Genetic Amplification and Mannan Antigenemia Coupled With Antimannan Antibodies in Intensive Care Patients With Suspected Invasive Candidiasis
The study consists in taking 4 tubes of blood at different times over a period of 10 days, via a catheter (central venous or arterial catheter) already in place in the usual therapeutic management. These samples will make it possible to measure blood levels of certain markers specific to invasive candidiasis. PCR will be used to quantify fungal load precisely, that is to say the quantity of yeast present in the blood and to monitor this quantity over time.
These samples will be transferred to a specialized unit and stored for a maximum of three years for use at the end of the study.
- Being tested
- Blood sample taken on the day the treatment is initiated, Blood sample taken on day 3 after initiation of treatment, Blood sample taken on day 5 after initiation of, Blood sample taken on day 7 after initiation of treatment, Blood sample taken on day 10 after initiation of treatment
- Medical subject headings
- Candidiasis, Invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample taken on the day the treatment is initiatedBiological
Blood sample taken on day 3 after initiation of treatmentBiological
Blood sample taken on day 5 after initiation ofBiological
Blood sample taken on day 7 after initiation of treatmentBiological
Blood sample taken on day 10 after initiation of treatmentBiological
| Study group | Role | What they receive |
|---|---|---|
| patients with suspected invasive candidiasis | Not described Receives: Biological: Blood sample taken on the day the treatment is initiated; Biological: Blood sample taken on day 3 after initiation of treatment; Biological: Blood sample taken on day 5 after initiation of; Biological: Blood sample taken on day 7 after initiation of treatment; Biological: Blood sample taken on day 10 after initiation of treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the start of treatment in genomic DNA of Candida sp. by quantitative PCR
Measured: At day 1, day 3, day 5, Day 7 and Day 10 after the start of antifungal treatment with echinocandin.
Secondary outcomes (1)
Change from the start of treatment in mannan antigenemia and antimannan antibodies
Measured: At day 1, day 5 and day 10 after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study start12 Jun 2015
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Candidiasis; Treatment With EchinocandinStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333448
- Sponsor's protocol ID
- Charles MSD 2014
- Acronym
- EMPIRICAND
- Status last verified
- Feb 2024
- First submitted
- 5 Dec 2014
- Last updated
- 20 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of PCR Genetic Amplification and Mannan Antigenemia Coupled With Antimannan Antibodies in Intensive Care Patients With Suspected Invasive Candidiasis
- ClinicalTrials.gov ID
- NCT02333448
- Acronym / sponsor ID
- EMPIRICAND / Charles MSD 2014
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 12 Jun 2015 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 7 Jan 2015 (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 study consists in taking 4 tubes of blood at different times over a period of 10 days, via a catheter (central venous or arterial catheter) already in place in the usual therapeutic management. These samples will make it possible to measure blood levels of certain markers specific to invasive candidiasis. PCR will be used to quantify fungal load precisely, that is to say the quantity of yeast present in the blood and to monitor this quantity over time.
These samples will be transferred to a specialized unit and stored for a maximum of three years for use at the end of the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with suspected invasive candidiasis | – | Biological: Blood sample taken on the day the treatment is initiated, Biological: Blood sample taken on day 3 after initiation of treatment, Biological: Blood sample taken on day 5 after initiation of, Biological: Blood sample taken on day 7 after initiation of treatment, Biological: Blood sample taken on day 10 after initiation of treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients in a medical Intensive Care Patients with suspected invasive candidiasis
Key inclusion criteria (8 listed)
- Patient informed about the study
- Patients aged at least 18 years admitted to a medical Intensive Care or general intensive care
- Patients with suspected invasive candidiasis - that is to say:
- Presenting persistent sepsis despite broad-spectrum antibiotherapy for at least 48 hours or targeted antibiotherapy for a documented bacterial infection (sepsis will be defined according to:
- Candida score ≥ 3 with multifocal colonization
Key exclusion criteria (3 listed)
- Treatment with echinocandin > 1 day in the week preceding inclusion
- Patients not covered by national health insurance
- Pregnant or breast-feeding women
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 |
|---|---|---|
| Blood sample taken on the day the treatment is initiated | Biological | patients with suspected invasive candidiasis |
| Blood sample taken on day 3 after initiation of treatment | Biological | patients with suspected invasive candidiasis |
| Blood sample taken on day 5 after initiation of | Biological | patients with suspected invasive candidiasis |
| Blood sample taken on day 7 after initiation of treatment | Biological | patients with suspected invasive candidiasis |
| Blood sample taken on day 10 after initiation of treatment | Biological | patients with suspected invasive candidiasis |
Primary outcome
Change from the start of treatment in genomic DNA of Candida sp. by quantitative PCR
Time frame: At day 1, day 3, day 5, Day 7 and Day 10 after the start of antifungal treatment with echinocandin.
1 secondary outcome
Change from the start of treatment in mannan antigenemia and antimannan antibodies
Time frame: At day 1, day 5 and day 10 after the start of treatment
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 20 Feb 2024.
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 Invasive Candidiasis; Treatment With Echinocandin, run by Centre Hospitalier Universitaire Dijon 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 8 inclusion and 3 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 20 Feb 2024. 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?
Change from the start of treatment in genomic DNA of Candida sp. by quantitative PCR (time frame: At day 1, day 3, day 5, Day 7 and Day 10 after the start of antifungal treatment with echinocandin.). 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 Feb 2024.