Fungal InfectionEIFINCT04647539
Emerging Invasive Fungal Infections in Critically Ill Patients
An observational study of Fungal Infection and ICU Acquired Weakness, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Rationale: Beside Candida and Aspergillus, emerging invasive fungal infections (EIFIs) are increasing in intensive care setting and are associated with high morbidity and mortality. However, data are scarce, particularly in ICU settings and for EIFIs other than mucormycosis. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Fungal Infection, ICU Acquired Weakness
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2006to 23 Nov 2020
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients majeurs hospitalisés en reanimation et présentant une infection fongique invasive autre qu'une candidose ou une aspergilloses
Who may be able to join
- Adults (≥ 18 years old) with at least 1 positive culture for molds other than candida and aspergillosis
Who cannot join
- Age < 18, pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emerging Invasive Fungal Infections in Critically Ill Patients: Epidemiological Trends, Clinical Features and Outcomes
Rationale: Beside Candida and Aspergillus, emerging invasive fungal infections (EIFIs) are increasing in intensive care setting and are associated with high morbidity and mortality. However, data are scarce, particularly in ICU settings and for EIFIs other than mucormycosis.
Objectives: to describe epidemiological trends and clinical features of EIFIs in intensive care units (ICU) and to assess their outcome.
Methods: All records of adult patients diagnosed with an EIFI in a medical ICU between 2006 and 2019 were analyzed retrospectively. In-ICU mortality was assessed, then factors associated with mortality were identified. Survival at day-90 was calculated by the Kaplan-Meier method.
- Conditions
- Fungal Infection, ICU Acquired Weakness
- Keywords
- Emergind invasive fungal infection, mucormycosis, ICU
- Medical subject headings
- Mycoses, Mucormycosis
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
mortality
Measured: at ICU admission
Secondary outcomes (1)
Mucormycosis
Mucormycosis
Measured: at ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start1 Jan 2006
- Primary completion1 Dec 2019
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romaric Larcher, MD, PharmD, MSc, Principal investigator, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647539
- Sponsor's protocol ID
- RECHMPL20_0626
- Acronym
- EIFI
- Status last verified
- Nov 2020
- First submitted
- 23 Nov 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emerging Invasive Fungal Infections in Critically Ill Patients: Epidemiological Trends, Clinical Features and Outcomes
- ClinicalTrials.gov ID
- NCT04647539
- Acronym / sponsor ID
- EIFI / RECHMPL20_0626
- Conditions
- Fungal Infection, ICU Acquired Weakness
- Keywords
- Emergind invasive fungal infection, mucormycosis, ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 1 Dec 2020 (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.
Rationale: Beside Candida and Aspergillus, emerging invasive fungal infections (EIFIs) are increasing in intensive care setting and are associated with high morbidity and mortality. However, data are scarce, particularly in ICU settings and for EIFIs other than mucormycosis.
Objectives: to describe epidemiological trends and clinical features of EIFIs in intensive care units (ICU) and to assess their outcome.
Methods: All records of adult patients diagnosed with an EIFI in a medical ICU between 2006 and 2019 were analyzed retrospectively. In-ICU mortality was assessed, then factors associated with mortality were identified. Survival at day-90 was calculated by the Kaplan-Meier method.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients majeurs hospitalisés en reanimation et présentant une infection fongique invasive autre qu'une candidose ou une aspergilloses
Key inclusion criteria (1 listed)
- Adults (≥ 18 years old) with at least 1 positive culture for molds other than candida and aspergillosis
Key exclusion criteria (1 listed)
- Age < 18, pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality
Time frame: at ICU admission
mortality
1 secondary outcome
Mucormycosis
Time frame: at ICU admission
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 1 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Romaric Larcher, MD, PharmD, MSc principal investigator
UH Montpellier
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 Fungal Infection and ICU Acquired Weakness, run by University Hospital, Montpellier 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 1 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 1 Dec 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?
mortality (time frame: at ICU admission). 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 1 Dec 2020.