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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03774316
Other study ID # 2017_32
Secondary ID 2017-A03113-50
Status Recruiting
Phase
First received
Last updated
Start date January 28, 2019
Est. completion date September 2023

Study information

Verified date October 2022
Source University Hospital, Lille
Contact Saad Nseir, MD,PhD
Phone 03 20 44 44 95
Email saad.nseir@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A small proportion of intensive care unit patients receiving antifungals have a proven invasive fungal infection. However, antifungal treatment has side effects such as toxicity, emergence of resistance, and high cost. Moreover, empirical antifungal treatment is still a matter for debate in these patients. Our study aimed to determine the incidence, associated factors, and safety of de-escalation of antifungals in immunocompromised critically ill patients. This prospective observational study is conducted in 14 ICU, during a 6 months period. All immunocompromised patients hospitalized for >5d and treated with antifungals for suspected or proven invasive candida infection will be included De-escalation is defined as a reduction in antifungal spectrum or stopping initial drugs within the 5 days following their initiation. The three antifungals considered in this study are from the narrowest to the widest spectrum: fluconazole, caspofungin and liposomal amphotericin B.


Description:

This is a retrospective and prospective observational multicenter study, aiming to determine the incidence, and safety of antifungal de-escalation in immunocompromised patients, and also factors associated with de-escalation.


Recruitment information / eligibility

Status Recruiting
Enrollment 296
Est. completion date September 2023
Est. primary completion date September 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults immunocompromised patients hospitalized in intensive care units - Predictable invasive mechanical ventilation duration > 96h - Signed consent (by patient or its representative) - First antifungal treatment initiation in ICU for proven or suspected candida infection Exclusion Criteria: - Pregnant or breast-feeding women. - Fungal infection other than invasive candida - Prophylactic antifungal treatment. - Lack of informed consent - Predictable mechanical ventilation duration less than 48 hours - Patients discharged from ICU before the 5th day after initiation of TAF

Study Design


Locations

Country Name City State
France CHU Lille Lille

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients with de-escalation of antifungal treatment De-escalation is defined as a reduction in antifungal treatment spectrum (switch from echinocandines or Amphotericin B to Azoles) or stopping all antifungals within the 5 days following their initiation 5 days following start of antifungal treatment
Secondary Risk factors for de-escalation of antifungal therapy Clinical characteristics and conditions significantly associated with de-escalation by univariate analysis will be entered in a multiple regression model to determine those independently associated with de-escalation during the 5 days following start of antifungal
Secondary Number of days free of mechanical ventilation days with no mechanical ventilation until day 28 after start of antifungal treatment
Secondary Number of days free of antifungal treatment days with no antifungal treatment until day 28 after start of antifungal treatment
Secondary Length of ICU stay days in the ICU until day 28 after start of antifungal treatment
Secondary All-cause mortality mortality related to any cause until day 28 after start of antifungal treatment
Secondary Percentage of patients with reoccurrence of candidiasis reccurrence of candidiasis is defined as a new episode after the end of antifungal treatment until day 7 after stop of antifungal treatment
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