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Completed

NCT Number: NCT04502771

Therapeutic Drug Monitoring of Antifungals in Intensive Care Units

Antifungals under- and over-dosing are frequently deplored in patients treated with antifungals and receiving recommended doses, mostly in critically-ill patients. This situation is well-described for antifungals from the azoles class mostly in patients with liver dysfunction or having concomitant drugs that may interact with azoles. This situation is less-described using echinocandins, although recent studies reported caspofungin underdosing for critically-ill patients. Considering that antifungals under-dosing was demonstrated to be associated with an increase in mortality, it is of utmost importance to analyse the relevance of therapeutic drug monitoring (TDM) for patients admitted in intensive care units (ICU). This will help to identify which patients are the more prone to antifungal under or over-dosing. Indeed, antifungals under-dosing may favour the development of clinical resistance to antifungals and increase mortality, whereas over-dosing may result in adverse events that may lead to treatment discontinuation.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon, Croix-Rousse Hospital

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients who received antifungals including fluconazole, voriconazole, posaconazole, or caspofungin, during their ICU stay and had a Therapeutic Drug Monitoring (TDM)

Exclusion criteria

  • Patients without antifungal treatment
  • Patients who received an antifungal combination
  • Pediatric patients
  • Patients who were not admitted in ICU
  • Patients who did not have a TDM

Treatment and study plan

Antifungal treatment

Drug

Treatment by fluconazole, voriconazole,posaconazole or caspofungin during the patient stay in Intensive Care Unit

Primary outcomes

  1. Antifungal blood concentration of patients admitted in intensive care units

    Time frame: Day 5 after antifungal initiation

Secondary outcomes

  1. Adverse event

    Time frame: Day 30 after antifungal initiation

    Impact of antifungal blood concentration on occurrence of adverse events and mycological failure

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Therapeutic Drug Monitoring of Antifungals in Patients From Intensive Care Units: a Retrospective Study

Acronym: Fungi-up

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 6, 2020
Registry last updated
Aug 7, 2020

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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