NCT06929494

Brief Summary

Candidal sepsis (candidemia) is a criticals problem in patients hospitalized in the intensive care unit, with a significant impact on morbidity and mortality. Risk factors for candidemia in intensive care patients included age, presence of a central venous catheter, inpatient surgery, and administration of parenteral nutrition (TPN). Mortality in patients with candidemia is estimated at 50-60%. Early identification and treatment, including control of the source of infection, are essential to improve morbidity and mortality in these patients. In this study, we would like to identify risk factors for the development of candidemia in intensive care patients, including those who have not undergone abdominal surgery, and to examine what percentage of patients who developed candidemia were given empirical antifungal therapy and what factors influenced the decision to give or not to give such empirical therapy. Study design: A retrospective study based on data collection from computerized systems will include patients who were hospitalized in the intensive care unit from January 2014 to December 2024 and were diagnosed with Candida in at least one blood culture.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

April 8, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 16, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

April 8, 2025

Last Update Submit

April 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Identification of risk factors for candidemia

    Identification of risk factors for candidemia

    Throughout ICU stay (from admission to 28 days post ICU discharge)

Interventions

Identification of risk factors for candidemia

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the ICU from January 2014 to December 2024 and had at least one positive blood culture for candidemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 8, 2025

First Posted

April 16, 2025

Study Start

August 1, 2025

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

April 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations