POSACOVID: Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Critically-ill COVID-19 patients receiving posaconazole prophylaxis
|
Drug: Posaconazole
Intravenous posaconazole prophylaxis
|
| Critically-ill COVID-19 patients without antifungal prophylaxis
|
Outcome Measures
Primary Outcome Measures
- 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
- Survival at ICU discharge [ICU admission to ICU discharge. On average 20 days]
Compare the rates of survival at time of discharge from the ICU in those who receive posaconazole compared to those who do not
- Length of ICU stay [ICU admission to ICU discharge. On average 20 days]
Compare the length of ICU stay in those who receive posaconazole compared to those who do not
- Mortality rate at 30 days [ICU admission until 30 days after ICU admission]
Compare the mortality rate at 30 days in those who receive posaconazole compared to those who do not
- Mortality rate at 90 days [ICU admission until 90 days after ICU admission]
Compare the mortality rate at 90 days in those who receive posaconazole compared to those who do not
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of Graz | Graz | Styria | Austria | 8036 |
| 2 | University of Rennes | Rennes | France | 35033 | |
| 3 | San Martino Polyclinic Hospital IRCCS | Genova | Italy | 16132 |
Sponsors and Collaborators
- Medical University of Graz
- Merck Sharp & Dohme LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 32-296 ex 19/20