Candida PCR Diagnosis Strategy in Patients From Intensive Care Units (CANDI-PCR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Candida
• Intervention / Treatment: Diagnostic test: Diagnosis strategy based on C. glabrata / krusei PCR

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pamela CHAUVIN; Phone Number: 05 67 69 04 09; Email: chauvin.p@chu-toulouse.fr
• Study Contact Backup: Name: Xavier IRIART; Phone Number: 05 67 69 04 99; Email: iriart.x@chu-toulouse.fr

Study Locations

• France
  • Occitanie
    • Toulouse, Occitanie, France, 31000
      • Recruiting
      • Uh Toulouse
      • Contact: PAMELA CHAUVIN, MD; Email: CHAUVIN.P@CHU-TOULOUSE.FR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: blood culture-based diagnostic strategy; Patients from intensive care units with suspected invasive candidiasis initially treated with echinocandins and who benefited from a blood culture-based diagnostic strategy
Experimental: C. glabrata / krusei PCR diagnostic strategy; Patients from intensive care units with suspected invasive candidiasis initially treated with echinocandins and who benefited from a diagnostic strategy based on C. glabrata / krusei PCR	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Pamela CHAUVIN, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2022
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: candidemia; DNA; Polymerase Chain Reaction; antifungal agents
• Other Study ID Numbers: RC31/19/0507

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No