Variations in plasma levels during the switch from IV to oral administration of voriconazole

Pharmacokinetic evaluation of the voriconazole IV to oral switch - Voriconazole IV to oral switch

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002085-12-BE

Enrollment

Registered

2012-04-27

Start date

2012-06-11

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult and pediatric hematology patients treated with intravenous voriconazole to cure an invasive fungal infection, and ready to switch from intravenous to oral administration of voriconazole MedDRA version: 14.1 Level: LLT Classification code 10042941 Term: Systemic fungal infection NOS System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Vfend Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: VORICONAZOLE CAS Number: 137234-62-9 Concentration unit: mg milligram(s) Concentration type: equal Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult hematology patients suffering from an invasive fungal infection, therefore treated with intravenous voriconazole, ready to take oral voriconazole. Pediatric hematology patients between 5-18 years suffering from an invasive fungal infection, treated with intravenous voriconazole, ready to take oral voriconazole. Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: less than 5 years of age, women who are pregnant/lactating, patients suffering from severe mucositis (WHO grade 3 or 4), patients treated with drugs interacting with voriconazole (rifampicine, rifabutin, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz, barbiturates, quinidine, ergotamine, sirolimus, saquinavir, amprenavir, nelfinavir, delvardine, ritonavir, sulphonylureas.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the pharmacokinetics of voriconazole during the switch from intravenous to oral administration;Secondary Objective: Optimization of antifungal therapy during switch from intravenous to oral administration of voriconazole;Primary end point(s): Pharmacokinetics of voriconazole during switch from intravenous to oral administration. ;Timepoint(s) of evaluation of this end point: Blood samples will be taken on the last day of intravenous voriconazole therapy and on the first four days of oral voriconazole therapy.	—

Measure

Time frame

Main Objective: Evaluation of the pharmacokinetics of voriconazole during the switch from intravenous to oral administration;Secondary Objective: Optimization of antifungal therapy during switch from intravenous to oral administration of voriconazole;Primary end point(s): Pharmacokinetics of voriconazole during switch from intravenous to oral administration. ;Timepoint(s) of evaluation of this end point: Blood samples will be taken on the last day of intravenous voriconazole therapy and on the first four days of oral voriconazole therapy.

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactSponsor - Head Investigator

University Hospitals Leuven

kim.vanstraelen@uzleuven.be003216342339

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026