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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03799172
Other study ID # CRC_GHN_2019_001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date September 1, 2019

Study information

Verified date March 2020
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date September 1, 2019
Est. primary completion date February 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Echinocandin treatment
Patients received echinocandins as a first-line therapy after candidemia diagnosis according to the standard of care
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.

Locations

Country Name City State
France Hospices Civils de Lyon, Hôpital de la Croix-Rousse Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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