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Pharmacokinetics of Isavuconazole in Patients in the Intensive Care Unit

NCT04777058 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2022-10-26

No results posted yet for this study

Summary

20 patients admitted to the ICU department and receiving isavuconazole as part of standard care for the treatment of fungal infections will be included in the study. Between day 3 and 7, 8 samples will be collected at t = 0 (pre-dose), and t = 0.5, 1, 2, 4, 6, 8 and 12 hours after end of infusion to obtain a PK curve. An optional, additional sample can be collected after discontinuation of isavuconazole therapy if possible. Total and free isavuconazole concentrations will be determined. A pharmacokinetic model will be fitted to the data from all individuals simultaneously. Data will be analysed using non-linear mixed effects modelling (NONMEM).

Conditions

  • Invasive Fungal Infections
  • Pharmacokinetics
  • Intensive Care Unit

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2022-09-29
Completion
2022-09-29

Countries

  • Belgium
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04777058 on ClinicalTrials.gov