Echinocandins Versus Azoles for Candidemia Treatment (AntiCandiTreat)

Echinocandins Versus Azoles as First-line Therapy for the Treatment of Candidemia in Intensive Care Units

Candidemia is the most frequent invasive fungal disease in intensive care units (ICUs). It remains a major health concern, considering its attributable mortality up to 40% in critically ill patients. Successful clinical outcome requires early diagnosis and effective antifungal therapy. Guidelines for the treatment of candidemia were published by the Infectious Diseases Society of America (IDSA) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). According to these guidelines, echinocandins are the preferred first-line therapy for candidemia in critically ill patients. Considering the bibliography supporting this statement, the place of triazoles still needs to be defined in candidemia therapeutic arsenal. In this context, we are setting up a retrospective cohort study using Hospital database to compare the efficacy of echinocandins and azoles for the treatment of candidemia in intensive care units.

Study Overview

• Status: Completed
• Conditions: Candidemia
• Intervention / Treatment: Drug: Echinocandin treatment; Drug: Triazole treatment

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hospices Civils de Lyon, Hopital de la Croix-Rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of candidemia during their ICU stay

Description

Inclusion Criteria:

• Patients who had a diagnosis of candidemia during ICU stay and were treated with echinocandins or azoles

Exclusion Criteria:

• Patients with neutropenia
• Patients without antifungal treatment
• Patients who received antifungal therapy for more than two days before candidemia diagnosis
• Patients receiving liposomal amphotericin b or multiple antifungal agents as first-line therapy
• Patients who received less than 4 days of antifungal therapy after candidemia diagnosis

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Echinocandin group; Echinocandin group is the group of patients who received echinocandins as first-line therapy for candidemia	Drug: Echinocandin treatment; Patients received echinocandins as a first-line therapy after candidemia diagnosis according to the standard of care
Triazole group; Triazole group is the group of patients who received triazoles as first-line therapy for candidemia	Drug: Triazole treatment; Patients received triazoles as a first-line therapy after candidemia diagnosis according to the standard of care. Candidemia was defined as at least one blood culture positive for Candida.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of all cause hospital mortality on day 90 between echinocandins and azoles	Comparison of all cause hospital mortality on day 90 between echinocandins and azoles	Mortality on day 90 after antifungal initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of treatment success on day 30 between echinocandins and azoles.	Treatment success is defined as a complete response if the following two criteria were full-filled: survival and resolution of all attributable symptoms and signs of disease, and mycological success (documented clearance of pathogen from the blood).	Treatment success on day 30 after antifungal initiation

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (Actual): January 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections and Mycoses; Sepsis; Mycoses; Invasive Fungal Infections; Fungemia; Candidiasis; Candidiasis, Invasive; Candidemia; Anti-Infective Agents; Antifungal Agents; Echinocandins
• Other Study ID Numbers: CRC_GHN_2019_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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