NCT07544342

Brief Summary

The study is aimed to assess the risk factors for acquiring candida auris skin colonization during an outbreak in an ICU.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Feb 2026Sep 2026

First Submitted

Initial submission to the registry

February 15, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

April 22, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 15, 2026

Last Update Submit

April 15, 2026

Conditions

Keywords

colonizationICUcandida auris

Outcome Measures

Primary Outcomes (1)

  • 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.

    From hospitalization in ICU until 2 weeks following discharge from ICU, a maximum of 90 days.

Study Arms (2)

Non colonized

Patient not colonized with candida auris

Colonized

Patient colonized with candida auris

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients hospitalized in ICU

You may qualify if:

  • hospitalization in ICU
  • Screened for candida auris

You may not qualify if:

  • Age \<18 yeas.
  • No data.
  • No candida screen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barzilai Medical Center

Ashkelon, Israel

Location

Related Publications (5)

  • 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.

    PMID: 32984882BACKGROUND
  • 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.

    PMID: 30922129BACKGROUND
  • 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.

    PMID: 37401661BACKGROUND
  • 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.

    PMID: 34155414BACKGROUND
  • 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.

    PMID: 32062286BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of infection control

Study Record Dates

First Submitted

February 15, 2026

First Posted

April 22, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

April 22, 2026

Record last verified: 2026-02

Locations