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Azole-echinocandin Combination Therapy for Invasive Aspergillosis

NCT04876716 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-05-07

No results posted yet for this study

Summary

The goals of this study are 3-fold:

First, the main study and the primary endpoint will evaluate if the overall mortality can be decreased with initial azole-echinocandin combination therapy compared with triazole monotherapy in patients with IA and documented voriconazole susceptibility.

Second, the study design described will also allow to study several other subpopulations; Indeed, the outcome of the following subgroups will be evaluated as well; a. Patients starting azole monotherapy but who switch to directed therapy when it has become clear that the infection is caused by an azole resistant A. fumigatus. b. patients in which eventually no resistance data become available in relation to the treatment they received.

Third, the study will evaluate what the outcome is of patients that turn out to be infected with a triazole resistant A. fumigatus who started with a triazole-echinocandin combination therapy.

Conditions

  • Invasive Aspergillosis

Interventions

DRUG

Azole

Dosing according to the SPC

DRUG

Anidulafungin

200mg loading dose on day 1 and 100mg QD thereafter

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Stichting Hemato-Oncologie voor Volwassenen Nederland

    collaborator OTHER

  • Erasmus Medical Center

    lead OTHER

Principal Investigators

  • Bart Rijnders, MD, PhD · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-11
Primary Completion
2024-05-01
Completion
2024-05-01

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04876716 on ClinicalTrials.gov