Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients

Medical University of Graz249 enrolled

Overview

COVID-19 associated pulmonary aspergillosis (CAPA) is considered a potentially life-threatening infection in critically ill COVID (Corona Virus disease)-19 patients. This study will investigate the efficacy of mold-active prophylaxis with posaconazole for patients with severe SARS (severe acute respiratory syndrome)-CoV-2 infection admitted to the ICU (intensive care unit) in a multi-center case-control study in Europe.

Study Type

OBSERVATIONAL

Enrollment

249

Conditions

COVID-19 Respiratory Infection Aspergillosis

Interventions

PosaconazoleDRUG

Intravenous posaconazole prophylaxis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patient (\> 18 years) * PCR (polymerase chain reaction) -confirmed SARS-CoV-2 infections based on nasopharyngeal swab (NPS), oropharyngeal swab (OPS), tracheal aspirate (TA), bronchial aspirate (BA), or bronchoalveolar lavage fluid (BALF) within 14 days prior to ICU admission or within 72 hours following ICU admission due to severe COVID-19 infection * Radiographic imaging consistent with SARS-CoV-2 infection (e.g. atypical pneumonia, organizing pneumonia, ground glass opacities) or ARDS within 7 days of diagnosis of SARS-CoV-2 infection Exclusion Criteria: * Patients with a diagnosis of invasive aspergillosis/detection of Aspergillus spp. by culture from sputum, TA, BA, or BALF or positive GM from serum, TA, or BALF at baseline (=ICU admission) * History of invasive aspergillosis within the prior six months * Patients that are being treated with mold-active antifungal agents for invasive aspergillosis or another invasive fungal infection * Patients that are being treated with mold-active antifungal agents for invasive aspergillosis or another invasive fungal infection * Death or transfer to general ward within 48 hours of ICU admission * Antifungal prophylaxis other than posaconazole (e.g. inhaled amphotericin B)

Locations (3)

Medical University of Graz

Graz, Styria, Austria

University of Rennes

Rennes, France

San Martino Polyclinic Hospital IRCCS

Genova, Italy

Outcomes

Primary Outcomes

Incidence of COVID-19 Associated Pulmonary Aspergillosis (CAPA)

Compare the incidence of CAPA at time of discharge from the ICU in those who received posaconazole compared to controls who did not

Time frame: ICU admission to ICU discharge. On average 20 days

Secondary Outcomes

Risk Factors for CAPA Development (EORTC/MSGERC)

This Outcome Measure examines whether the presence of an EORTC/MSGERC-defined risk factor at ICU admission is associated with an increased risk of developing COVID-19-associated pulmonary aspergillosis (CAPA) during the ICU stay. The analysis is conducted using a cohort of patients admitted to the ICU, tracking the development of CAPA from ICU admission to ICU discharge. For this purpose, the number of subjects who had underlying EORTC/MSGERC risk factors present at ICU admission was collected and used as a parameter in a multivariate logistic model to assess the association with an increased risk for CAPA development.

Time frame: ICU admission to ICU discharge. On average 20 days

Risk Factors for CAPA Development (ECMO)

This Outcome Measure examines whether the need for extracorporal membrange oxygenation (ECMO) treatment during ICU admission is associated with an increased risk of developing COVID-19-associated pulmonary aspergillosis (CAPA) during the ICU stay. The analysis is conducted using a cohort of patients admitted to the ICU, tracking the development of CAPA from ICU admission to ICU discharge. For this purpose, the number of subjects who required ECMO treatment during ICU stay was collected and used as a parameter in a multivariate logistic model to assess the association with an increased risk for CAPA development.

Time frame: ICU admission to ICU discharge. On average 20 days

Data from ClinicalTrials.gov

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