Candida PCR Diagnosis Strategy in Patients From Intensive Care Units

Candida Clinical Trial

— CANDI-PCR  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04874441
• Other study ID #: RC31/19/0507
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2022
• Est. completion date: August 1, 2025

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: Pamela CHAUVIN
• Phone: 05 67 69 04 09
• Email: chauvin.p[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Candida

Intervention

Diagnostic Test:
• Diagnosis strategy based on C. glabrata / krusei PCR
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

Locations

Country	Name	City	State
France	Uh Toulouse	Toulouse	Occitanie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reporting delay	the time (in hours) required for the results to be returned in relation to the time of sample collection	14 days after blood sample taken
Secondary	mortality at Day 28	Mortality rates will be taken 28 days after taking blood samples for Candida diagnosis in both groups	28 days after blood sample taken