Invasive Candidiasis in Critical Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-11

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The combination of acute phase marker monitoring and the "T2Candida" assay (name of the test) will represent an acceleration of the identification of the causative agent of mycotic infection, a significant improvement in the specificity and positive predictive value of this strategy in the diagnosis of invasive candidiasis and candidemia in ICU patients, thereby improving the clinical condition of patients and reducing the cost of specific antifungal therapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Candida PCR Diagnosis Strategy in Patients From Intensive Care Units

NCT04874441

Candida

RECRUITING NA

Diagnostic Performance of the CandID PLUS PCR for the Diagnosis of Intra-abdominal Candidiasis in Critically Ill Patients

NCT07005258

Intra-Abdominal Infection Candida Peritonitis Infectious +2 more

COMPLETED

Early Identification of Candida in Intra-abdominal Candidiasis

NCT05264571

Candida Sepsis Candidiasis, Invasive Peritonitis Infectious +1 more

COMPLETED

Characterizing Diversity and Antifungal Resistance in Immunocompromised ICU Patients With Respiratory Tract Infections

NCT06387667

Immunocompromised ICU Patients With Respiratory Tract Infections

NOT_YET_RECRUITING NA

A Multicenter Observational Study of Invasive Candida Infections Among ICU Patients in China

NCT01253954

Candidiasis

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Speed of response in the treatment of sepsis is crucial for the patient. The time from the collection of a positive haemoculture to the identification of the causative agent of sepsis is around 2 days; therefore, physicians in intensive care units deploy combined empiric antibiotic and antifungal therapy immediately when acute phase markers such as procalcitonin, interleukin-6, Presepsin, C-reactive protein are elevated. A new acute phase marker is lipopolysaccharide-binding protein, which, together with Presepsin, appears to be a suitable marker to distinguish invasive candida infections from bacterial infections. But its kinetics needs to be further analyzed.

At the same time, the causative agent of sepsis, G-/G+ bacteria or yeast, must be identified as soon as possible. Haemoculture and culture of the established drain is the gold standard, but the disadvantage is the low sensitivity and the time delay to obtain the result. It is therefore advisable to combine haemoculture with molecular biology-based tests that can identify the causative organism within hours. Conversely, the disadvantage of these tests is that they identify only the most common sepsis pathogens and do not determine susceptibility to antibiotics and antifungals, but the advantage is that with prophylaxis in place, these tests are often positive when haemoculture is negative. The T2Candida test can detect Candida albicans, Candida tropicalis, Candida glabrata, Candida krusei and Candida parapsilosis, which are the more common causative agents of mycotic bloodstream infections.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Invasive Candidiasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with suspected invasive candidiasis

Patients with suspected invasive candidiasis will be enrolled in this study arm.

Invasive candidiasis test

Intervention Type DIAGNOSTIC_TEST

The combination of acute phase marker monitoring and the T2Candida assay will be assessed.

Urine sample collection for future research

Intervention Type OTHER

Patients will be asked to provide a urine sample for future research (urine biobank).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Invasive candidiasis test

The combination of acute phase marker monitoring and the T2Candida assay will be assessed.

Intervention Type DIAGNOSTIC_TEST

Urine sample collection for future research

Patients will be asked to provide a urine sample for future research (urine biobank).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* critically ill patients
* new onset sepsis
* rise in body temperature \>38°C according to The Third Consensus Definitions for Sepsis and Septic Shock
* colonization with Candida spp. from more than 1 non-sterile site
* body temperature \>38 °C despite 5 days of broad-spectrum antibiotic therapy with the presence of at least 1 of the following risk factors: abdominal surgery, secondary peritonitis, pancreatitis, central venous catheter (CVC) insertion, total parenteral nutrition (CPV), dialysis, steroid therapy, immunosuppressive therapy, or liver transplantation
* microbiological test results will be reviewed and categorized based on whether Candida sp. is isolated from at least 2 non-sterile sites (±3 days) and whether there is an alternative microbiological diagnosis.

Exclusion Criteria

* not signing the informed consent with participation in the study
* administration of antifungal therapy prior to collection of the biological material required for the study

Minimum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No