NCT00893555

Brief Summary

The objective of this study proposal is to determine whether pharmacologic optimization of voriconazole by means of therapeutic drug monitoring (TDM) results in improved patient outcomes (efficacy and safety) and is more cost-effective compared to the current standard of care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

7.6 years

First QC Date

May 4, 2009

Last Update Submit

January 11, 2017

Conditions

Invasive Fungal InfectionHematological Malignancy

Keywords

Invasive fungal infectionhematological malignancyvoriconazoletherapeutic drug monitoring

Outcome Measures

Primary Outcomes (1)

  • The primary clinical endpoint will be a global response consisting of a combined endpoint of toxicity and response to therapy (clinical, microbiologic and radiologic responses) 28 days after starting treatment with voriconazole.

    28 days

Secondary Outcomes (6)

  • Overall mortality

    7 and 28 days; 12 weeks

  • % of serum concentrations within 2-5mg/L

    7 and 28 days; 12 weeks

  • % switched to salvage therapy or measured concentration level in control arm

    7 and 28 days; 12 weeks

  • Side effects

    7 and 28 days; 12 weeks

  • Time to global response

    7 and 28 days; 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

control

ACTIVE COMPARATOR

Voriconazole dosing based on SPC

Drug: voriconazole (dosing according to the SPC)

TDM

EXPERIMENTAL

Voriconazole serum concentration based dosing

Drug: voriconazole

Interventions

voriconazoleDRUG

TDM (through level of 2-5mg/L).

Also known as: Vfend
TDM
voriconazole (dosing according to the SPC)DRUG

No serum concentrations are determined

Also known as: Vfend
control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • are at least 18 years of age
  • have received chemotherapy for haematological malignancies or have received a hematopoietic stem cell transplant
  • proven, probable or possible invasive fungal disease according to the EORTC/MSG criteria
  • treatment with voriconazole

You may not qualify if:

  • allergic to voriconazole or its excipients
  • age below 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

Location

Related Publications (2)

  • Klomp SD, Veringa A, Alffenaar JC, de Boer MGJ, Span LFR, Guchelaar HJ, Swen JJ. Inflammation altered correlation between CYP2C19 genotype and CYP2C19 activity in patients receiving voriconazole. Clin Transl Sci. 2024 Jul;17(7):e13887. doi: 10.1111/cts.13887.

    PMID: 39010708DERIVED

  • Veringa A, Bruggemann RJ, Span LFR, Biemond BJ, de Boer MGJ, van den Heuvel ER, Klein SK, Kraemer D, Minnema MC, Prakken NHJ, Rijnders BJA, Swen JJ, Verweij PE, Wondergem MJ, Ypma PF, Blijlevens N, Kosterink JGW, van der Werf TS, Alffenaar JC; Voriconazole ZonMw Study Group. Therapeutic drug monitoring-guided treatment versus standard dosing of voriconazole for invasive aspergillosis in haematological patients: a multicentre, prospective, cluster randomised, crossover clinical trial. Int J Antimicrob Agents. 2023 Feb;61(2):106711. doi: 10.1016/j.ijantimicag.2023.106711. Epub 2023 Jan 13.

    PMID: 36642232DERIVED

MeSH Terms

Conditions

Invasive Fungal InfectionsHematologic Neoplasms

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • J GW Kosterink, PharmD, PhD

    University Medical Center Groningen

    STUDY CHAIR

  • J WC Alffenaar, PharmD PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD PharmD

Study Record Dates

First Submitted

May 4, 2009

First Posted

May 6, 2009

Study Start

April 1, 2009

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

NL(1)