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Bioavailability of Voriconazole

U

University Medical Center Groningen (UMCG)

Status and phase

Withdrawn
Phase 4

Conditions

Voriconazole
Critically Ill
Bioavailability

Treatments

Other: Dosage form of voriconazole

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The objective of this study is to obtain the absolute bioavailability of voriconazole in critically ill ICU patients, because pharmacokinetics can be different in critically ill patients due to alterations in function of various organs and body systems compared with healthy volunteers.

Full description

The bioavailability of voriconazole, based on healthy volunteers, is estimated to be >90%. Due to the high bioavailability of voriconazole, switching between oral and intravenous administration is permitted if clinically allowed. Few data are available for the bioavailability of voriconazole in critically ill patients. However, to obtain a therapeutic concentration of voriconazole (>1.5 mg/L, which is associated with a beneficial response to treatment) one study showed that a higher oral dose is required compared with the intravenous dose, to obtain this therapeutic concentration. Therefore, the pharmacokinetics can be changed in critically ill patients, including bioavailability.

In this study, patients who receive voriconazole orally (prescribed by their attending physician) will receive one intravenous dose of voriconazole instead of the oral dose. The intravenous dose will be the same as the oral dose voriconazole.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Aged ≥ 18 yrs;
  • Treatment with voriconazole;
  • Admission to an ICU;
  • Written informed consent.

Exclusion criteria

  • Blood sampling by central venous catheter or peripheral cannula not possible;
  • Concomitantly using a strong inhibitor or inducer of cytochrome P450.

Trial design

0 participants in 1 patient group

Bioavailability
Other group
Description:
1 arm, different dosage form
Treatment:
Other: Dosage form of voriconazole

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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