Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04874441

Evaluation of a Candida PCR Diagnosis Strategy to Reduce Result Time in ICU Patients With Suspected Systemic Invasive Candidiasis

Led by University Hospital, Toulouse · Updated on 2024-08-02

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate a new method for diagnosing invasive candidiasis, a serious yeast infection, in patients in intensive care units. The study focuses on how this new PCR technique affects the time needed to get diagnostic results compared to the current blood culture method. Researchers hope this faster method will support earlier changes in antifungal treatment, potentially reducing resistance and lowering treatment costs. Participants will be divided into two groups: one will receive the standard diagnostic approach using blood cultures, and the other will be diagnosed using the new PCR method targeting Candida glabrata and krusei species. Both groups initially receive treatment with echinocandins. For those in the PCR group, an early switch to fluconazole is made if the PCR test is negative. This approach aims to improve treatment decisions and reduce delays. During the study, patients will be monitored at 14 and 28 days after diagnosis and until discharge or for up to 3 months if still hospitalized. Researchers will collect blood samples for both blood culture and PCR testing, track the timing of diagnostic results, monitor treatment changes, and record outcomes such as mortality. The study measures how quickly results are returned and the impact on antifungal treatment choices and patient survival.

CONDITIONS

Brief Title

Candida PCR Diagnosis Strategy in Patients From Intensive Care Units

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is affiliated with or benefits from a social protection system
  • Patient or their trusted person has given free and informed written consent
  • Non-neutropenic patient hospitalized in the Toulouse University Hospital intensive care unit
  • Patient has suspected invasive candidiasis with blood culture taken and started empirical echinocandin treatment at an appropriate dose
Not Eligible

You will not qualify if you...

  • Patients under guardianship or trusteeship or under court protection
  • Pregnant or breastfeeding patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 14 days

Participants undergo diagnostic testing using either blood culture or PCR to detect Candida species and guide treatment decisions.

1 to 2 visits depending on diagnostic strategy

Long-term Monitoring

Duration - Up to 3 months

Participants are monitored for clinical outcomes and treatment response up to 3 months or until hospital discharge.

Visits at Day 14, Day 28, and until discharge

Trial Site Locations

Total: 1 location

1

Uh Toulouse

Toulouse, Occitanie, France, 31000

Actively Recruiting

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Research Team

P

Pamela CHAUVIN

X

Xavier IRIART

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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