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NCT Number: NCT04874441

Candida PCR Diagnosis Strategy in Patients From Intensive Care Units

The aim of this study is to evaluate the implementation of a new technique for invasive candidiasis diagnosis by PCR. The main objective will be to evaluate the effect of this strategy on the time required to obtain results in patients from intensive care units with suspected systemic invasive candidiasis. This PCR method could allow an antifungal switch to be made earlier, limiting the appearance of resistance and reducing the cost of antifungals for healthcare facilities.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uh Toulouse

Toulouse, Occitanie, 31000, France

Location status: Recruiting

Location contact

PAMELA CHAUVIN, MD

CONTACT

[email protected]

About this study

Invasive candidiasis is a serious infection caused by yeasts of the genus Candida sp. Their incidence is increasing, particularly in intensive care. The prognosis is severe and depends on the early initiation of adequate antifungal treatment. At present, the diagnosis of invasive candidiasis is difficult since blood culture, the reference technique, has major limitations due to its low sensitivity, as well as very long delays in obtaining results. As a consequence, suspected invasive candidiasis is often treated empirically with echinocandins, resulting in the development of resistance and extremely high costs for health care facilities. The switch to treatments such as fluconazole is often delayed, although this molecule is effective on most Candida species except C. krusei and glabrata and is much less expensive than echinocandins.

For these reasons, the present study developed faster and more efficient methods to diagnose Candida krusei and glabrata species, based on the detection of DNA in the blood by PCR, allowing an earlier switch from echinocandins to Fluconazole.

The patients included will be divided into 2 groups: one group of patients will benefit from a diagnostic strategy based on blood culture (reference technique for the detection of Candida) and another group of patients will benefit from a diagnostic strategy based on this new PCR technique. The main objective will be to evaluate the effect of the PCR strategy on the time to obtain results and on the switch of antifungal agents. After inclusion, patients will be followed up at day 14, day 28 until discharge (or 3 months if the patient is still hospitalised).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient affiliated or benefiting from a social protection system
  • Patient (or his/her trusted person) having given free and informed written consent to the investigating physician
  • Non-neutropenic patient hospitalised in the Toulouse University Hospital intensive care unit.
  • Patient with suspected invasive candidiasis for whom a blood culture for fungal infection diagnosis was taken and for whom an empirical treatment with echinocandin at an adapted dose was implemented.

Exclusion criteria

  • Patients under guardianship or trusteeship, persons under court protection
  • Pregnant or breastfeeding patients.

Treatment and study plan

Diagnosis strategy based on C. glabrata / krusei PCR

Diagnostic Test

For diagnosis, a blood cultures and blood tubes for PCR will be collected and patients will be treated with echinocandins in the first instance with an early switch to fluconazole if the C. glabrata / krusei PCR is negative

Primary outcomes

  1. Reporting delay

    Time frame: 14 days after blood sample taken

    the time (in hours) required for the results to be returned in relation to the time of sample collection

Secondary outcomes

  1. mortality at Day 28

    Time frame: 28 days after blood sample taken

    Mortality rates will be taken 28 days after taking blood samples for Candida diagnosis in both groups

Study contacts

Contact information is provided by the study sponsor or research team.

Pamela CHAUVIN

CONTACT

[email protected]

05 67 69 04 09

Xavier IRIART

CONTACT

[email protected]

05 67 69 04 99

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Evaluation of the Effect of the Implementation of a Candida PCR Diagnosis Strategy on the Time Required to Obtain Results in Patients From Intensive Care Units With Suspected Systemic Invasive Candidiasis: Pilot Study

Acronym: CANDI-PCR

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 5, 2021
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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