Aspergillosis in patients with severe influenza or coronavirus infectio

Not Applicable

Completed

• Conditions: Aspergillosis; Infections and Infestations; Invasive aspergillosis in intensive care patients with severe influenza or COVID-19

• Registration Number: ISRCTN51287266
• Lead Sponsor: St George’s University Hospitals NHS Foundation Trust

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37657925/ (added 13/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-06
• Study Completion: 2023-08-15
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 357

Inclusion Criteria

Current inclusion criteria as of 13/01/2022:
1. Adults > 18 years
2. Admitted to ICU for respiratory support requiring intubation and ventilation for >24h
AND EITHER:
3. Positive influenza or SARS-CoV-2 PCR from nasal, throat swab, BAL or other respiratory specimen taken either < 7 days pre, or < 3 days post, admission to ICU
OR
4. Influenza or SARS-CoV-2 suspected but PCR results awaited – under these circumstances the patient can be provisionally enrolled, but later excluded if no specimens taken within either < 7 days pre, or < 3 days post admission to ICU positive as above
OR
5. Clinically suspected bacterial lower respiratory tract infection with associated radiological changes (pneumonia) encompassing both community and hospital-acquired pneumonia diagnosed =72hrs prior to ICU admission or =48 hours after admission. These patients must not have tested positive for influenza or SARS-CoV-2 PCR during their hospital admission

Previous inclusion criteria as of 26/03/2020 - 13/01/2022:
1. Adults aged >18 years
2. Admitted to ICU for respiratory support requiring intubation and ventilation for >24 hours
AND EITHER:
3. Positive influenza or SARS-CoV-2 PCR from nasal, throat swab, BAL or other respiratory specimen taken either < 7 days pre, or < 3 days post, admission to ICU
OR
4. Influenza or SARS-CoV-2 suspected but PCR results awaited – under these circumstances the patient can be provisionally enrolled, but later excluded if no specimens taken within either < 7 days pre, or < 3 days post admission to ICU positive as above

Previous inclusion criteria:
1. Adults > 18 years
2. Admitted to intensive care for respiratory support requiring intubation and ventilation for > 24 hours
AND EITHER:
3. Positive influenza PCR from nasal, throat swab, BAL or other respiratory specimen taken within 48 hours (of admission to ICU – pre or post
OR
4. Influenza suspected but influenza PCR results awaited – under these circumstances the patient can be provisionally enrolled, but later excluded if no specimens taken within 48 hours pre/post admission to ICU is positive as above

Exclusion Criteria

1. Respiratory failure not the primary reason for ICU admission
2. History of proven/ probable invasive pulmonary aspergillosis

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Incidence and risk factors for invasive aspergillosis (IA) in the study cohort (as per modified AspICU criteria):<br>1.1. Diagnostic classification of Influenza-associated aspergillosis (IAA) during ICU admission as per modified AspICU criteria, determined at the end of ICU stay<br>1.2. Risk factors to be elicited from baseline clinical data points collected at enrolment (within three days of ICU admission) and ICU therapeutics/interventions collected at the end of ICU stay