Candida PCR Diagnosis Strategy in Patients From Intensive Care Units

NCT04874441 | Recruiting

• 1 other identifier: RC31/19/0507
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Candida

Keywords

candidemia; Polymerase Chain Reaction; DNA; antifungal agents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• mortality at Day 28

  28 days after blood sample taken

Study Arms (2)

blood culture-based diagnostic strategy

NO INTERVENTION

Patients from intensive care units with suspected invasive candidiasis initially treated with echinocandins and who benefited from a blood culture-based diagnostic strategy

C. glabrata / krusei PCR diagnostic strategy

EXPERIMENTAL

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

Interventions

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

C. glabrata / krusei PCR diagnostic strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Uh Toulouse

Toulouse, Occitanie, 31000, France

RECRUITING

MeSH Terms

Conditions

Torulopsis; Candidemia

Condition Hierarchy (Ancestors)

Candidiasis, Invasive; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pamela CHAUVIN, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela CHAUVIN

CONTACT

05 67 69 04 09; chauvin.p@chu-toulouse.fr

Xavier IRIART

CONTACT

05 67 69 04 99; iriart.x@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 5, 2021
• Study Start: May 19, 2022
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

FR (1)