Candida Auris ColonizationNCT07544342
Assessment of Risk Factors for Acquiring Colonization With Candida Auris During an Outbreak in ICU.
An observational study of Candida Auris Colonization, run by Barzilai Medical Center at 1 site in Israel.
Trial summary
The study is aimed to assess the risk factors for acquiring candida auris skin colonization during an outbreak in an ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candida Auris Colonization
- How many people
- 771 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Feb 2026to 1 May 2026
- 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
- Adult, Older adult
Study population: All patients hospitalized in ICU
Who may be able to join
- hospitalization in ICU
- Screened for candida auris
Who cannot join
- Age <18 yeas.
- No data.
- No candida screen.
Trial locations and contacts
1 site in 1 country.
About this study
The study is aimed to assess the risk factors for acquiring candida auris skin colonization during an outbreak in an ICU.
Read the 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.
- Conditions
- Candida Auris Colonization
- Keywords
- colonization, ICU, candida auris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non colonized | Patient not colonized with candida auris | |
| Colonized | Patient colonized with candida auris |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonization with Candida auris
Positive screening for candida auris, taken by nose/ armpits and groin swabs and either directly seeded on a selective medium or by positive PCR.
Measured: From hospitalization in ICU until 2 weeks following discharge from ICU, a maximum of 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start15 Feb 2026
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Candida Auris ColonizationStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 771 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barzilai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Daniel Leshin Carmel, Barzilai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544342
- Sponsor's protocol ID
- BRZ-0103-25
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 32984882Ruiz-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.
PubMed 30922129Mulet 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.
PubMed 37401661Proctor 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.
PubMed 34155414Shastri 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.
PubMed 32062286
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Risk Factors for Acquiring Colonization With Candida Auris During an Outbreak in ICU.
- ClinicalTrials.gov ID
- NCT07544342
- Acronym / sponsor ID
- BRZ-0103-25
- Conditions
- Candida Auris Colonization
- Keywords
- colonization, ICU, candida auris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 771 participants (actual)
- Lead sponsor
- Barzilai Medical CenterUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 22 Apr 2026 (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.
The study is aimed to assess the risk factors for acquiring candida auris skin colonization during an outbreak in an ICU.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non colonized | – | –Patient not colonized with candida auris |
| Colonized | – | –Patient colonized with candida auris |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients hospitalized in ICU
Key inclusion criteria (2 listed)
- hospitalization in ICU
- Screened for candida auris
Key exclusion criteria (3 listed)
- Age <18 yeas.
- No data.
- No candida screen.
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
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.
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 May 2026.
- Background: PubMed 32984882Rossow 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.
- Background: PubMed 30922129Ruiz-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.
- Background: PubMed 37401661Mulet 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.
- Background: PubMed 34155414Proctor 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.
- Background: PubMed 32062286Shastri 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.
- Individual participant dataSharing planned: Undecided
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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.
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 Candida Auris Colonization, run by Barzilai Medical Center at 1 site in Israel.
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 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 May 2026. 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 Israel. 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?
Colonization with Candida auris (time frame: From hospitalization in ICU until 2 weeks following discharge from ICU, a maximum of 90 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 NCT07544342, which also lists 5 linked publications.
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 May 2026.