- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07544342
Assessment of Risk Factors for Acquiring Colonization With Candida Auris During an Outbreak in ICU.
May 18, 2026 updated by: Dr. Daniel Leshin Carmel, Barzilai Medical Center
The study is aimed to assess the risk factors for acquiring candida auris skin colonization during an outbreak in an ICU.
Study Overview
Status
Completed
Conditions
Detailed Description
Candida auris is unique when compared to other pathogenic fungi, as it spreads in the hospital rapidly.
Therefore, it can cause healthcare-associated infections and outbreaks, it is resistant to antimicrobials and disinfectants and it is persisting on human skin and in the inanimate environment.
There are few works listing factors found associated with candida auris candidemia, including longer CVC days, prior antibiotics, mechanical ventilation and longer ICU stay.
Most of the research for candida auris risk factor doesn't differentiate colonization and infection, or, focuses on risk factors leading from colonization to infection.
The study is aimed to assess the risk factors for acquiring candida auris skin colonization during an outbreak in an ICU.
Study Type
Observational
Enrollment (Actual)
771
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ashkelon, Israel
- Barzilai Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
All patients hospitalized in ICU
Description
Inclusion Criteria:
- hospitalization in ICU
- Screened for candida auris
Exclusion Criteria:
- Age <18 yeas.
- No data.
- No candida screen.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Non colonized
Patient not colonized with candida auris
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Colonized
Patient colonized with candida auris
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Colonization with Candida auris
Time Frame: From hospitalization in ICU until 2 weeks following discharge from ICU, a maximum of 90 days.
|
Positive screening for candida auris, taken by nose/ armpits and groin swabs and either directly seeded on a selective medium or by positive PCR.
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From hospitalization in ICU until 2 weeks following discharge from ICU, a maximum of 90 days.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rossow J, Ostrowsky B, Adams E, Greenko J, McDonald R, Vallabhaneni S, Forsberg K, Perez S, Lucas T, Alroy KA, Jacobs Slifka K, Walters M, Jackson BR, Quinn M, Chaturvedi S, Blog D; New York Candida auris Investigation Workgroup. Factors Associated With Candida auris Colonization and Transmission in Skilled Nursing Facilities With Ventilator Units, New York, 2016-2018. Clin Infect Dis. 2021 Jun 1;72(11):e753-e760. doi: 10.1093/cid/ciaa1462.
- Ruiz-Gaitan A, Martinez H, Moret AM, Calabuig E, Tasias M, Alastruey-Izquierdo A, Zaragoza O, Mollar J, Frasquet J, Salavert-Lleti M, Ramirez P, Lopez-Hontangas JL, Peman J. Detection and treatment of Candida auris in an outbreak situation: risk factors for developing colonization and candidemia by this new species in critically ill patients. Expert Rev Anti Infect Ther. 2019 Apr;17(4):295-305. doi: 10.1080/14787210.2019.1592675. Epub 2019 Mar 29.
- Mulet Bayona JV, Tormo Palop N, Salvador Garcia C, Guna Serrano MDR, Gimeno Cardona C. Candida auris from colonisation to candidemia: A four-year study. Mycoses. 2023 Oct;66(10):882-890. doi: 10.1111/myc.13626. Epub 2023 Jul 4.
- Proctor DM, Dangana T, Sexton DJ, Fukuda C, Yelin RD, Stanley M, Bell PB, Baskaran S, Deming C, Chen Q, Conlan S, Park M; NISC Comparative Sequencing Program; Welsh RM, Vallabhaneni S, Chiller T, Forsberg K, Black SR, Pacilli M, Kong HH, Lin MY, Schoeny ME, Litvintseva AP, Segre JA, Hayden MK. Integrated genomic, epidemiologic investigation of Candida auris skin colonization in a skilled nursing facility. Nat Med. 2021 Aug;27(8):1401-1409. doi: 10.1038/s41591-021-01383-w. Epub 2021 Jun 21.
- Shastri PS, Shankarnarayan SA, Oberoi J, Rudramurthy SM, Wattal C, Chakrabarti A. Candida auris candidaemia in an intensive care unit - Prospective observational study to evaluate epidemiology, risk factors, and outcome. J Crit Care. 2020 Jun;57:42-48. doi: 10.1016/j.jcrc.2020.01.004. Epub 2020 Jan 9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2026
Primary Completion (Actual)
May 1, 2026
Study Completion (Actual)
May 1, 2026
Study Registration Dates
First Submitted
February 15, 2026
First Submitted That Met QC Criteria
April 15, 2026
First Posted (Actual)
April 22, 2026
Study Record Updates
Last Update Posted (Actual)
May 20, 2026
Last Update Submitted That Met QC Criteria
May 18, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BRZ-0103-25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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