NCT03799172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

January 3, 2019

Last Update Submit

March 3, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Comparison of treatment success on day 30 between echinocandins and azoles.

    Treatment success on day 30 after antifungal initiation

Study Arms (2)

Echinocandin group

Echinocandin group is the group of patients who received echinocandins as first-line therapy for candidemia

Drug: Echinocandin treatment

Triazole group

Triazole group is the group of patients who received triazoles as first-line therapy for candidemia

Drug: Triazole treatment

Interventions

Patients received echinocandins as a first-line therapy after candidemia diagnosis according to the standard of care

Echinocandin group

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.

Triazole group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a diagnosis of candidemia during their ICU stay

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon, Hôpital de la Croix-Rousse

Lyon, 69004, France

Location

MeSH Terms

Conditions

Candidemia

Condition Hierarchy (Ancestors)

Candidiasis, InvasiveCandidiasisMycosesBacterial Infections and MycosesInfectionsInvasive Fungal InfectionsFungemiaSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 10, 2019

Study Start

November 1, 2018

Primary Completion

February 1, 2019

Study Completion

September 1, 2019

Last Updated

March 4, 2020

Record last verified: 2020-03

Locations