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Posaconazole for the Prevention of Influenza-associated Aspergillosis in Critically Ill Patients

NCT03378479 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-04-08

Study results available
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Summary

The objective of this study is to deliver proof of concept that antifungal prophylaxis can reduce the incidence of Influenza Associated Aspergillosis (IAA) in ICU (intensive care unit) patients with severe influenza.

The investigators will perform an interventional non-blinded randomized controlled multicentric proof-of-concept study in patients with severe influenza admitted to the ICU. Patients will be randomized to the posaconazole prophylaxis group or to the SOC (standard of care) group. Oseltamivir will be started at the discretion of the investigator. Patients in the posaconazole group will receive posaconazole prophylaxis for 7 days.

addendum: pharmacokinetics of posaconazole as prophylaxis for invasive fungal disease on ICU

Conditions

  • Aspergillosis; Pulmonary, Invasive (Etiology)

Interventions

DRUG

SOC +Posaconazole 18 MG/ML (milligram/milliliter)

.2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days (total 7 days)

OTHER

standard of care (SOC)

treatment for influenza pneumonia at the investigators discretion

Sponsors & Collaborators

Principal Investigators

  • Joost Wauters, Phd · UZ Leuven

  • Paul Verweij, Phd · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-27
Primary Completion
2020-03-31
Completion
2021-03-30

Countries

  • Belgium
  • France
  • Netherlands

Study Locations

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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 NCT03378479 on ClinicalTrials.gov