N/A
N=249
Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients
COVID-19 Respiratory Infection · Aspergillosis
Bottom Line
View on ClinicalTrials.gov: NCT05065658 ↗Enrolled (actual)
249
Serious AEs
100.0%
Results posted
Feb 2025
Primary outcome: Primary: Incidence of COVID-19 Associated Pulmonary Aspergillosis (CAPA) — 1.69; 0.84; 7.18 Cases per 1000 ICU days
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Posaconazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of Graz
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of COVID-19 Associated Pulmonary Aspergillosis (CAPA) |
1.69; 0.84; 7.18 | — |
| SECONDARY Risk Factors for CAPA Development (EORTC/MSGERC) |
8; 7; 4 | — |
| SECONDARY Risk Factors for CAPA Development (ECMO) |
13; 2; 4 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05065658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.