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Completed

NCT Number: NCT05065658

Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients

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.

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Key information

Conditions

COVID-19 Respiratory Infection Aspergillosis Bacterial Infections and Mycoses Infections Mycoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz, Graz, Styria, Austria

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Posaconazole

Drug

Intravenous posaconazole prophylaxis

Primary outcomes

  1. Incidence of COVID-19 Associated Pulmonary Aspergillosis (CAPA)

    Time frame: 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 outcomes

  1. Risk Factors for CAPA Development (EORTC/MSGERC)

    Time frame: 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.

  2. Risk Factors for CAPA Development (ECMO)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Posaconazole for the Prevention of COVID-19 Associated Pulmonary Aspergillosis in Critically-Ill Patients: A European Multicenter Case-Control Study

Acronym: POSACOVID

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 4, 2021
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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