Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients

Completed

Brief Summary: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Critically-ill COVID-19 patients receiving posaconazole prophylaxis	Posaconazole	-

Primary Outcome Measures

Name	Time	Method
Incidence of COVID-19 Associated Pulmonary Aspergillosis (CAPA)	ICU admission to ICU discharge. On average 20 days	Compare the incidence of CAPA at time of discharge from the ICU in those who received posaconazole compared to controls who did not

Secondary Outcome Measures

Name	Time	Method
Risk Factors for CAPA Development (EORTC/MSGERC)	ICU admission to ICU discharge. On average 20 days	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.
Risk Factors for CAPA Development (ECMO)	ICU admission to ICU discharge. On average 20 days	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.

Locations (3): San Martino Polyclinic Hospital IRCCS
🇮🇹
Genova, Italy
University of Rennes
🇫🇷
Rennes, France
Medical University of Graz
🇦🇹
Graz, Styria, Austria