Early Discontinuation of Empirical Antifungal Therapy and Biomarkers (SEAT)

University Hospital, Lille

Status: Enrolling

Conditions: Invasive Candidiasis

Treatments: Other: Routine strategy; Other: Biomarker strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT03538912

2017_07

2017-003793-13 (EudraCT Number)

Details and patient eligibility

About

Empirical antifungal therapy (EAT) is frequently prescribed to septic critically ill patients with risk factors for invasive Candida infections (ICI). However, among patients without subsequent proven ICI, antifungal discontinuation is rarely performed, resulting in unnecessary antifungal overuse.

The investigators postulate that the use of fungal biomarkers could increase the percentage of early discontinuation of EAT among critically ill patients suspected of ICI, as compared with a standard strategy, without negative impact on day 28-mortality.

To test this hypothesis, the investigators designed a randomized controlled open-label parallel-group study.

Full description

Patients requiring EAT will be randomly assigned to:

• intervention group: a strategy in which EAT duration is determined by (1,3)-B-Dglucan and mannan serum assays, performed on day 0 (day of EAT initiation) and day 3. Early stop recommendation, provided before day 7, will be determined using an algorithm based on the results of biomarkers.
• control group: a routine care strategy, based on international guidelines, which recommend 14 days of treatment for patients without subsequent proven ICI, and who improve under antifungal treatment, or less in other situations.

Enrollment: 194 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient older than 18 years
• Who require EAT for the first time in the ICU (this treatment is prescribed based on the presence of risk factors and clinical suspicion of ICI)
• With an expected ICU length of stay of at least 6 days after EAT initiation
• Informed written consent

Exclusion criteria

• Neutropenia (neutrophil count <500 cells /µL)
• Active malignant hemopathy
• Bone marrow transplantation in the last 6 months
• Polyvalent immunoglobulins in the past months
• Documented ICI in the past 3 months
• Pregnancy or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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194 participants in 2 patient groups

Biomarker group

Other group

Description:

patient follow the Biomarker strategy

Treatment:

Other: Biomarker strategy

Routine group

Other group

Description:

patient follow the routine strategy

Treatment:

Other: Routine strategy