Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients

NCT05065658 | Completed Results

• 1 other identifier: 32-296 ex 19/20
• Study Type: observational
• Target: 249
• Locations: 3 countries
• Sites: 3

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.

Conditions

COVID-19 Respiratory Infection; Aspergillosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Risk Factors for CAPA Development (EORTC/MSGERC)

  ICU admission to ICU discharge. On average 20 days

• Risk Factors for CAPA Development (ECMO)

  ICU admission to ICU discharge. On average 20 days

Study Arms (2)

Critically-ill COVID-19 patients receiving posaconazole prophylaxis

Drug: Posaconazole

Critically-ill COVID-19 patients without antifungal prophylaxis

Interventions

Posaconazole DRUG

Intravenous posaconazole prophylaxis

Critically-ill COVID-19 patients receiving posaconazole prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be comprised of patients admitted to the ICU because of severe SARS-CoV-2 infections, who are requiring mechanical ventilation and receive dexamethasone as part of their COVID-19 ARDS treatment in medical centers in i) Graz, Austria (cases), and ii) Genoa, Italy, and iii) Rennes, France (all controls). Posaconazole prophylaxis for ICU patients with severe COVID-19 requiring ICU admission due to ARDS has been introduced in Graz in July 2020, and cases from Graz will be matched with controls from Rennes and Genoa (matching for days on mechanical ventilation at baseline, Apache II score, age, dexamethasone dosage, and underlying disease).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Graz: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (3)

Medical University of Graz

Graz, Styria, 8036, Austria

Location

University of Rennes

Rennes, 35033, France

Location

San Martino Polyclinic Hospital IRCCS

Genova, 16132, Italy

Location

Related Publications (1)

• Prattes J, Giacobbe DR, Marelli C, Signori A, Dettori S, Cattardico G, Hatzl S, Reisinger AC, Eller P, Krause R, Reizine F, Bassetti M, Gangneux JP, Hoenigl M. Posaconazole for Prevention of COVID-19-Associated Pulmonary Aspergillosis in Mechanically Ventilated Patients: A European Multicentre Case-Control Study (POSACOVID). Mycoses. 2025 Jan;68(1):e70023. doi: 10.1111/myc.70023.

  PMID: 39800852 DERIVED

MeSH Terms

Conditions

Aspergillosis

Interventions

posaconazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Dr. Juergen Prattes
• Organization: Medical University of Graz

juergen.prattes@medunigraz.at

004331638530046

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 4, 2021
• Study Start: March 1, 2020
• Primary Completion: August 23, 2023
• Study Completion: August 23, 2023
• Last Updated: February 17, 2025
• Results First Posted: February 17, 2025

Record last verified: 2025-01

Locations

FR (1); AU (1); IT (1)