CandidiasisNCT01322698
Staging Candidiasis in ICU Patients
An observational study of Candidiasis, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
Our primary objective is to evaluate the relevance of the early determination of Candida infection status among non-neutropenic patients hospitalized over 48 hours in ICUs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidiasis
- What is being tested?
- Tests for candidiasis
- Type of treatment
- Pill or oral medicine
- How many people
- 422 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2011to 7 Oct 2014
- 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: The target population includes patients in ICUs at the Nîmes and Montpellier University hospitals. This is a population of non-neutropenic patients (polynuclear neutrophils > 500/mm3) at risk of developing invasive candidiasis.
Who may be able to join
- Polynuclear neutrophils > 500/mm^3
- Hospitalized for > 48 hours in participating ICUs
Who cannot join
- Patients discharged from ICU in < 48h
- Patient diagnosed with invasive candidosis before entry to ICU
- Patient is taking an anti-fungal treatment
- polynuclear neutrophils < 500/mm^3
- patient transferred to another ICU
- patient included in the Abmidex protocole
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Montpellier
Montpellier, 34090
CHU de Nîmes
Nîmes, Gard, 30029
About this study
Our primary objective is to evaluate the relevance of the early determination of Candida infection status among non-neutropenic patients hospitalized over 48 hours in ICUs.
- Conditions
- Candidiasis
- Being tested
- Tests for candidiasis
- Keywords
- ICU
- Medical subject headings
- Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tests for candidiasisBiological
Tests include (1) anti-candida antibody ELISA kit; (2) candida antigen ELISA kit; (3) detection of circulating Candida DNA via SYBR Breen qPCR Master mix; (4) colonization index based on mycological examination of five out of the following: urine, oral swab, bronchial aspirate, anal swab, swab of a central venous line, gastric liquid.
| Study group | Role | What they receive |
|---|---|---|
| The study population | The target population includes patients in ICUs at the Nîmes and Montpellier University hospitals. This is a population of non-neutropenic patients (polynuclear neutrophils > 500/mm3) at risk of developing invasive candidiasis. Receives: Biological: Tests for candidiasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of positive Candidiasis tests
Number of tests (score of 0 to 4) positive for Candida. Tests include (1) anti-candida antibody ELISA kit; (2) candida antigen ELISA kit; (3) detection of ciruclating Candida DNA via SYBR Breen qPCR Master mix; (4) colonization index based on mycological examination of five out of the following: urine, oral swab, bronchial aspirate, anal swab, swab of a central venous line, gastric liquid.
Measured: 7 days
Secondary outcomes (4)
Number of positive Candidiasis tests
Number of tests (score of 0 to 4) positive for Candida. Tests include (1) anti-candida antibody ELISA kit; (2) candida antigen ELISA kit; (3) detection of ciruclating Candida DNA via SYBR Breen qPCR Master mix; (4) colonization index based on mycological examination of five out of the following: urine, oral swab, bronchial aspirate, anal swab, swab of a central venous line, gastric liquid.
Measured: 2 days
Patient leaves ICU unit, yes/no
Measured: 1 month
Patient passes away in ICU unit, yes/no
Measured: 1 month
Patient has been prescribed an antifungal treatment in the past month, yes/no
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startOct 2011
- Primary completion7 Oct 2014
- Study completion7 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence Lachaud, MD, Study director, Centre Hospitalier Universitaire de NīmesNathalie Bourgeois, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322698
- Sponsor's protocol ID
- AOI/2009/BL-01
- Other IDs
- 2010-A00858-31
- Status last verified
- Mar 2015
- First submitted
- 24 Mar 2011
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Larcher R, Platon L, Amalric M, Brunot V, Besnard N, Benomar R, Daubin D, Ceballos P, Rispail P, Lachaud L, Bourgeois N, Klouche K. Emerging Invasive Fungal Infections in Critically Ill Patients: Incidence, Outcomes and Prognosis Factors, a Case-Control Study. J Fungi (Basel). 2021 Apr 24;7(5):330. doi: 10.3390/jof7050330.
PubMed 33923333
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staging Candidiasis in ICU Patients
- ClinicalTrials.gov ID
- NCT01322698
- Acronym / sponsor ID
- AOI/2009/BL-01
- Conditions
- Candidiasis
- Keywords
- ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- 7 Oct 2014 (actual)
- Study completion
- 7 Oct 2014 (actual)
- First posted
- 25 Mar 2011 (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.
Our primary objective is to evaluate the relevance of the early determination of Candida infection status among non-neutropenic patients hospitalized over 48 hours in ICUs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Biological: Tests for candidiasisThe target population includes patients in ICUs at the Nîmes and Montpellier University hospitals. This is a population of non-neutropenic patients (polynuclear neutrophils > 500/mm3) at risk of developing invasive candidiasis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population includes patients in ICUs at the Nîmes and Montpellier University hospitals. This is a population of non-neutropenic patients (polynuclear neutrophils > 500/mm3) at risk of developing invasive candidiasis.
Key inclusion criteria (2 listed)
- Polynuclear neutrophils > 500/mm^3
- Hospitalized for > 48 hours in participating ICUs
Key exclusion criteria (6 listed)
- Patients discharged from ICU in < 48h
- Patient diagnosed with invasive candidosis before entry to ICU
- Patient is taking an anti-fungal treatment
- polynuclear neutrophils < 500/mm^3
- patient transferred to another ICU
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 |
|---|---|---|
| Tests for candidiasisTests include (1) anti-candida antibody ELISA kit; (2) candida antigen ELISA kit; (3) detection of circulating Candida DNA via SYBR Breen qPCR Master mix; (4) colonization index based on mycological examination of five out of the following: urine, oral swab, bronchial aspirate, anal swab, swab of a central venous line, gastric liquid. | Biological | The study population |
Primary outcome
Number of positive Candidiasis tests
Time frame: 7 days
Number of tests (score of 0 to 4) positive for Candida. Tests include (1) anti-candida antibody ELISA kit; (2) candida antigen ELISA kit; (3) detection of ciruclating Candida DNA via SYBR Breen qPCR Master mix; (4) colonization index based on mycological examination of five out of the following: urine, oral swab, bronchial aspirate, anal swab, swab of a central venous line, gastric liquid.
4 secondary outcomes
Number of positive Candidiasis tests
Time frame: 2 days
Patient leaves ICU unit, yes/no
Time frame: 1 month
Patient passes away in ICU unit, yes/no
Time frame: 1 month
Patient has been prescribed an antifungal treatment in the past month, yes/no
Time frame: 1 month
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 17 Nov 2025.
- Results publication: PubMed 33923333Larcher R, Platon L, Amalric M, Brunot V, Besnard N, Benomar R, Daubin D, Ceballos P, Rispail P, Lachaud L, Bourgeois N, Klouche K. Emerging Invasive Fungal Infections in Critically Ill Patients: Incidence, Outcomes and Prognosis Factors, a Case-Control Study. J Fungi (Basel). 2021 Apr 24;7(5):330. doi: 10.3390/jof7050330.
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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.
Laurence Lachaud, MD study director
Centre Hospitalier Universitaire de Nīmes
Nathalie Bourgeois, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Candidiasis, run by Centre Hospitalier Universitaire de Nīmes at 2 sites 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 2 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 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Number of positive Candidiasis tests (time frame: 7 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 NCT01322698, 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 17 Nov 2025; AzTrials last refreshed its copy on 30 Oct 2026.