AntiCandiTreat: Echinocandins Versus Azoles for Candidemia Treatment

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT03799172
Collaborator
(none)
79
1
10
7.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Echinocandin treatment
  • Drug: Triazole treatment

Study Design

Study Type:
Observational
Actual Enrollment :
79 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Echinocandins Versus Azoles as First-line Therapy for the Treatment of Candidemia in Intensive Care Units
Actual Study Start Date :
Nov 1, 2018
Actual Primary Completion Date :
Feb 1, 2019
Actual Study Completion Date :
Sep 1, 2019

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Comparison of all cause hospital mortality on day 90 between echinocandins and azoles [Mortality on day 90 after antifungal initiation]

    Comparison of all cause hospital mortality on day 90 between echinocandins and azoles

Secondary Outcome Measures

  1. Comparison of treatment success on day 30 between echinocandins and azoles. [Treatment success on day 30 after antifungal initiation]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospices Civils de Lyon, Hôpital de la Croix-Rousse Lyon France 69004

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT03799172
Other Study ID Numbers:
  • CRC_GHN_2019_001
First Posted:
Jan 10, 2019
Last Update Posted:
Mar 4, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 4, 2020