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NCT Number: NCT03538912

Early Discontinuation of Empirical Antifungal Therapy and Biomarkers

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.

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Key information

Conditions

Invasive Candidiasis Bacterial Infections and Mycoses Candidiasis Candidiasis, Invasive Infections Invasive Fungal Infections Mycoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH ARRAS, Arras, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biomarker strategy

Other

EAT duration is determined by β-D-1,3-glucan and mannan serum assays, performed at day 0 (day of EAT initiation) and day 3.

Routine strategy

Other

EAT duration is based on IDSA guidelines, which recommend 14 days of treatment for patients without subsequent proven ICI, and who improve under antifungal treatment, or less in other situations.

Primary outcomes

  1. percentage of patients receiving early discontinuation of EAT, defined as a discontinuation strictly before day 7 after EAT initiation

    Time frame: day 7 after EAT initiation

    This trial is designed to demonstrate whether, in critically ill patients suspected for ICI, the biomarker strategy, as compared with a standard strategy, is at the same time:

    • superior in terms of antifungal use and
    • Non-inferior in terms of death

Secondary outcomes

  1. death from any cause

    Time frame: day 28 after EAT initiation

    This trial is designed to demonstrate whether, in critically ill patients suspected for ICI, the biomarker strategy, as compared with a standard strategy, is at the same time:

    • superior in terms of antifungal use and
    • Non-inferior in terms of death

  2. percentage of patients who presented a proven ICI after EAT discontinuation

    Time frame: at day 28 or ICU discharge, if it occurs before day 28

  3. percentage of patients who received at least two periods of antifungal treatment (prescribed for separate episodes of suspected or proven ICI)

    Time frame: at day 28 or ICU discharge, if it occurs before day 28

  4. intensity of Candida colonization during ICU stay

    Time frame: at day 28 or ICU discharge, if it occurs before day 28

    Five body sites (among urine, anal swabs, pharyngeal swabs, nasal swabs, axillary swabs, gastric aspirates if patients have a nasogastric tube, and tracheal aspirates if patients are intubated or have a tracheotomy) are sampled on day 0 and then once per week for the semi-quantitative determination of yeast colonisation. The number of colony-forming units is scored as follows: score 1, <10 colony-forming units; score 2, 10 to 50 colony-forming units; score 3, >50 colony-forming units; score 4, >50 colony-forming units confluent. Intensity of colonization is determined for each date of sampling, by dividing the sum score for each colonized site by the number of sites sampled giving a mean Candida load. An overall score of >4 is possible in the case of isolation of several Candida species.

  5. percentage of patients colonized with a resistant strain of Candida

    Time frame: at day 28 or ICU discharge, if it occurs before day 28

  6. antifungal-free days

    Time frame: at day 28 or ICU discharge, if it occurs before day 28

  7. ventilator-free days

    Time frame: at day 28 or ICU discharge, if it occurs before day 28

  8. ICU-free days

    Time frame: at day 28 or ICU discharge, if it occurs before day 28

  9. ICU mortality

    Time frame: at day 28 or ICU discharge, if it occurs before day 28

  10. day 90 mortality

    Time frame: at day 90

  11. Characterization of the fungal intestinal microbiota studied by standard mycology

    Time frame: at baseline, at Day 7, day 14 day 21 and day 28

  12. Characterization of the fungal intestinal microbiota studied by metagenomics

    Time frame: at baseline, at Day 7, day 14 day 21 and day 28

  13. Characterization of the bacterial intestinal microbiota studied by culture bacteriology

    Time frame: at baseline, at Day 7, day 14 day 21 and day 28

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Impact of the Use of Biomarkers on Early Discontinuation of Empirical Antifungal Therapy in Critically Ill Patients: a Randomized Controlled Study.

Acronym: SEAT

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
May 29, 2018
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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