NCT04238884

Brief Summary

This is a phase IV pragmatic, multicentre, randomised, simple-blind, parallel arm, centre-stratified clinical trial. The main objective is to compare efficiency of voriconazole preemptive genotyping strategy, compared with routine practice.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

January 2, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

16 days

First QC Date

January 18, 2020

Last Update Submit

January 22, 2020

Conditions

Invasive Fungal Infections

Outcome Measures

Primary Outcomes (1)

  • Serum voriconazole concentration

    Serum voriconazole concentration within the therapeutic range, in μg/mL.

    Day 5 of treatment

Secondary Outcomes (4)

  • Therapeutic failure

    Within 3 months

  • Adverse event

    Within 3 months

  • Costs by adverse event

    Day 90 of treatment

  • Quality adjusted life years (QALY)

    Day 90 of treatment

Study Arms (2)

Experimental group

EXPERIMENTAL

Based on the genetic study carried out and the patient's characteristics (age, weight, indication), the Pharmacogenetics Unit of the University Hospital La Paz will indicate the dose to be administered based on the therapeutic individualization protocol guided by pharmacogenetics.

Drug: Voriconazole preemptive genotyping strategy

Control group

ACTIVE COMPARATOR

No information will be provided and procedure will be carried out according to normal clinical practice, with clinical monitoring by the doctor in charge.

Drug: Voriconazole clinical practice

Interventions

Voriconazole preemptive genotyping strategyDRUG

The patients who finally receives voriconazole will be randomized to receive the dose according to a pharmacogenetic algorithm including CYP2C19 genotype and clinical and demographic information.

Experimental group
Voriconazole clinical practiceDRUG

The patients who finally receives voriconazole will be randomized to receive the dose according to clinical practice

Control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient at risk of developing invasive aspergillosis, that will potentially receive treatment or prophylaxis with voriconazole:
  • A. Pediatric population: children who are going to receive a transplant of hematopoietic precursors (HSCT) and acute myeloid leukemias, as well as relapses of it.
  • B. Adult population: patients diagnosed with acute leukemia, and those patients with expected prolonged neutropenia, secondary to hematological process and / or after specific treatment (aplastic anemia and variants, myelodysplastic syndrome, solid organ or bone marrow transplant, etc.), and those whose responsible clinician consider individually that they could present a risk of developing a fungal infection.
  • Those who agree to participate in the study by signing informed consent (patients equal or over 18 years old)
  • Subjects under 18 years old whose representative / legal guardian has voluntarily signed the informed consent.
  • In the case of mature under 18 years subjects (12-17 years of age), in addition to the consent signed by the legal guardian, the consent of the subject will be obtained.

You may not qualify if:

  • Patients who for any reason should not be included in the study according to the criteria of the research team.
  • Subjects who are not capable to understand the information sheet and unable to sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Paz University Hospital

Madrid, 28046, Spain

RECRUITING

Related Publications (1)

  • Monserrat Villatoro J, Garcia Garcia I, Bueno D, de la Camara R, Estebanez M, Lopez de la Guia A, Abad-Santos F, Anton C, Mejia G, Otero MJ, Ramirez Garcia E, Frias Iniesta J, Carcas A, Borobia AM. Randomised multicentre clinical trial to evaluate voriconazole pre-emptive genotyping strategy in patients with risk of aspergillosis: vorigenipharm study protocol. BMJ Open. 2020 Oct 1;10(10):e037443. doi: 10.1136/bmjopen-2020-037443.

    PMID: 33004392DERIVED

MeSH Terms

Conditions

Invasive Fungal Infections

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Study Officials

  • Alberto M Borobia, MD, PhD

    La Paz University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto M Borobia, MD, PhD

CONTACT

+34-917277558alberto.borobia@salud.madrid.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2020

First Posted

January 23, 2020

Study Start

January 2, 2020

Primary Completion

January 18, 2020

Study Completion

December 31, 2022

Last Updated

January 23, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)