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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05065658
Other study ID # 32-296 ex 19/20
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date August 23, 2023

Study information

Verified date March 2024
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 information / eligibility

Status Completed
Enrollment 249
Est. completion date August 23, 2023
Est. primary completion date August 23, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Posaconazole
Intravenous posaconazole prophylaxis

Locations

Country Name City State
Austria Medical University of Graz Graz Styria
France University of Rennes Rennes
Italy San Martino Polyclinic Hospital IRCCS Genova

Sponsors (2)

Lead Sponsor Collaborator
Medical University of Graz Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

Austria,  France,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 ICU admission to ICU discharge. On average 20 days
Secondary Survival at ICU discharge Compare the rates of survival at time of discharge from the ICU in those who receive posaconazole compared to those who do not ICU admission to ICU discharge. On average 20 days
Secondary Length of ICU stay Compare the length of ICU stay in those who receive posaconazole compared to those who do not ICU admission to ICU discharge. On average 20 days
Secondary Mortality rate at 30 days Compare the mortality rate at 30 days in those who receive posaconazole compared to those who do not ICU admission until 30 days after ICU admission
Secondary Mortality rate at 90 days Compare the mortality rate at 90 days in those who receive posaconazole compared to those who do not ICU admission until 90 days after ICU admission