Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2023-08-23

Brief Summary

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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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Detailed Description

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Conditions

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COVID-19 Respiratory Infection Aspergillosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Critically-ill COVID-19 patients receiving posaconazole prophylaxis

Posaconazole

Intervention Type DRUG

Intravenous posaconazole prophylaxis

Critically-ill COVID-19 patients without antifungal prophylaxis

No interventions assigned to this group

Interventions

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Posaconazole

Intravenous posaconazole prophylaxis

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No