Aspergillosis in patients with severe influenza or coronavirus infection

Incidence and pathogenesis of invasive aspergillosis in intensive care patients with severe influenza or COVID-19 (AspiFlu)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN51287266

Enrollment

445

Registered

2019-12-06

Start date

2019-12-13

Completion date

Unknown

Last updated

2024-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Current intervention as of 24/08/2020: After consent and enrolment patients will undergo a baseline set of blood tests including serum (5 ml) and Paxgene DNA (2.5 ml). At the London study sites, perip

Eligibility

Sex/Gender

All

Inclusion criteria

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 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 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

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

Design outcomes

Primary

Measure	Time frame
1. Incidence and risk factors for invasive aspergillosis (IA) in the study cohort (as per modified AspICU criteria): 1.1. Diagnostic classification of Influenza-associated aspergillosis (IAA) during ICU admission as per modified AspICU criteria, determined at the end of ICU stay 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	—

Measure

Time frame

1. Incidence and risk factors for invasive aspergillosis (IA) in the study cohort (as per modified AspICU criteria): 1.1. Diagnostic classification of Influenza-associated aspergillosis (IAA) during ICU admission as per modified AspICU criteria, determined at the end of ICU stay 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

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Secondary

Measure	Time frame
Current secondary outcome measures as of 26/03/2020: 1. The incidence of IA in critically ill patients with influenza and a comparison group with COVID-19: 1.1. Diagnostic classification of COVID-19-associated aspergillosis during ICU admission using modified AspICU criteria as per patients with influenza 2. Morbidity and mortality associated with both influenza-associated IA and COVID-19-associated IA, measured by: 2.1. Duration (days) of mechanical ventilation at end of ICU stay 2.2. Duration (days) of ICU stay at end of ICU stay 2.3. Duration (days) of hospital stay at end of hospital stay 2.4. ICU all-cause mortality at end of ICU stay 2.5. Inpatient all-cause mortality at end of hospital stay 2.6. 90-day all-cause mortality at 90 days from study ICU admission 2.7. Survival analysis: time to death (all-cause mortality) for all patients at 90-days from study ICU admission 3. Utility of AspLFD device for diagnosis of IAA: sensitivity and specificity/negative and positive predictive values measured by diagnostic evaluation of results using stored samples against AspICU criteria. Performed retrospectively at a subsequent time after the influenza season Previous secondary outcome measures: 1. Morbidity and mortality of IAA, measured by: 1.1. Duration (days) of mechanical ventilation at end of ICU stay 1.2. Duration (days) of ICU stay at end of ICU stay 1.3. Duration (days) of hospital stay at end of hospital stay 1.4. ICU all-cause mortality at end of ICU stay 1.5. Inpatient all-cause mortality at end of hospital stay 1.6. 90-day all-cause mortality at 90 days from study ICU admission 1.7. Survival analysis: time to death (all-cause mortality) for all patients at 90-days from study ICU admission 2. Utility of AspLFD device for diagnosis of IAA: sensitivity and specificity/negative and positive predictive values measured by diagnostic evaluation of results using stored samples against AspICU criteria. Performed retrospectively at a subsequent time after the influenza	—

Measure

Time frame

Current secondary outcome measures as of 26/03/2020: 1. The incidence of IA in critically ill patients with influenza and a comparison group with COVID-19: 1.1. Diagnostic classification of COVID-19-associated aspergillosis during ICU admission using modified AspICU criteria as per patients with influenza 2. Morbidity and mortality associated with both influenza-associated IA and COVID-19-associated IA, measured by: 2.1. Duration (days) of mechanical ventilation at end of ICU stay 2.2. Duration (days) of ICU stay at end of ICU stay 2.3. Duration (days) of hospital stay at end of hospital stay 2.4. ICU all-cause mortality at end of ICU stay 2.5. Inpatient all-cause mortality at end of hospital stay 2.6. 90-day all-cause mortality at 90 days from study ICU admission 2.7. Survival analysis: time to death (all-cause mortality) for all patients at 90-days from study ICU admission 3. Utility of AspLFD device for diagnosis of IAA: sensitivity and specificity/negative and positive predictive values measured by diagnostic evaluation of results using stored samples against AspICU criteria. Performed retrospectively at a subsequent time after the influenza season Previous secondary outcome measures: 1. Morbidity and mortality of IAA, measured by: 1.1. Duration (days) of mechanical ventilation at end of ICU stay 1.2. Duration (days) of ICU stay at end of ICU stay 1.3. Duration (days) of hospital stay at end of hospital stay 1.4. ICU all-cause mortality at end of ICU stay 1.5. Inpatient all-cause mortality at end of hospital stay 1.6. 90-day all-cause mortality at 90 days from study ICU admission 1.7. Survival analysis: time to death (all-cause mortality) for all patients at 90-days from study ICU admission 2. Utility of AspLFD device for diagnosis of IAA: sensitivity and specificity/negative and positive predictive values measured by diagnostic evaluation of results using stored samples against AspICU criteria. Performed retrospectively at a subsequent time after the influenza

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Countries

England, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026