BeNeFIT18558: Behandlung der invasiven Aspergillose durch eine Kombination aus Azol und Echinocandin Eine pragmatische randomisierte Überlegenheitsstudie - DUET-Studie

Zusammenfassung (Niederländisch oder Französisch oder Englisch)

Trial Description
Title Behandlung der invasiven Aspergillose durch eine Kombination aus Azol und Echinocandin Eine pragmatische randomisierte Überlegenheitsstudie - DUET-Studie

Participants (P)

Immunocompromised patients who fulfil the EORTC/MSG host factor and mycological criteria of invasive aspergillosis

ICU patients with influenza who fulfil a definition of IA specific for this population.

Intervention (I)

initial therapy consists of a triazole and an echinocandin in combination

Control (C)

initial therapy of triazole monotherapy

Outcome (O)

Overall mortality 42 days after the start of antifungal therapy in the MITT population

Trial Design

Large pragmatic randomised superiority trial

Sample Size

650 patients

Trial duration

49 months

Budget

2,626,098 € (incl. VAT) of which

The Netherlands: 1,906,020 € including VAT

Belgium: 720,078 € including VAT

Status

Open

 

Trial team

Sponsor

Erasmus Medical Centre, The Netherlands

Coordinating centre: University hospital Leuven

Chief Investigator

Bart J.A. Rijnders

National Coordinator BE: Johan Maertens

 

Trial coordinator

 

Sites- GPs

30 Hospitals (15 in Belgium and 15 in The Netherlands)

External Partners

HOVON

Dokumente
Protocol  
Report

Q3 2024

Publication

Q3 2024

REFERENZEN

Clinicaltrials.gov: pending

Webpage: 

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