Critically ill patients with suspected fungal infection or proven fungal infection Infections and Infestations Critically ill patients with suspected fungal infection
Conditions
Interventions
The A-STOP Study is a multi-centre, prospective, diagnostic test accuracy study. The purpose of this project is to assess the performance of three rapid tests for fungal infection. The accuracy of the
children
patients with end organ dysfunction, assessed using SOFA and PELOD score (for adults and children respectively)
prior antifungal exposure
patients with infection due to different Candida species
and patients with candidaemia.
At least 35 paediatric and adult intensive care units (ICUs) across the UK participate. Adult and paediatric patients admitted to the ICU who are started on presumptive
Sponsors
The Queen's University of Belfast
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 11/04/2019: 1. Adults and children >4 weeks old 2. Admitted to a UK ICU (level 2 or 3) 3. Prescribed systemic antifungal therapy, for suspected or confirmed Candida infection, during the preceding 24 hours Previous participant inclusion criteria: 1. Adults and children >4 weeks old 2. Admitted to a UK ICU (level 2 or 3) 3. Started systemic antifungal therapy, for presumed Candida infection, during the preceding 24 hours
Exclusion criteria
Exclusion criteria: 1. More than 24 hours systemic antifungal therapy in the preceding 7-days 2. Treatment with antifungal therapy for proven or suspected mould infection (eg.e.g. aspergillosis) 3. Neutropenia (absolute neutrophil count <0.5x109/L) during preceding 28 days 4. Acute leukaemia or within 12 months of bone-marrow transplantation 5. Hospitalised prisoners 6. Previously enrolled in this study Added 26/10/2021: 7. Proven or suspected active infection with COVID-19
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy is measured using the negative predictive value for each index test | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Measures of diagnostic test accuracy, for each test alone and in combination, based on an international consensus reference standard for proven invasive fungal disease, applied for Candida infection. These will comprise sensitivity, specificity, positive/negative predictive values and positive/negative likelihood ratios. 2. Measures of diagnostic test accuracy, for each test alone and in combination, based on an international consensus reference standard for proven and probable invasive fungal disease, applied for Candida infection. 3. Estimated proportion of patients receiving systemic antifungal therapy in this cohort for whom treatment is unnecessary, derived from the reference standards used. Estimated number of days’ avoidable antifungal treatment if negative index test results were used to stop treatment. 4. Development of a test-based protocol using the index tests (alone or in combination), as a strategy for early cessation of empirical antifungal treatment, with assessment of its expected cost-effectiveness modelled on test accuracy, disease prevalence and clinical/economic outcomes in this patient group. | — |
Countries
England, Northern Ireland, United Kingdom, Wales
Contacts
Public ContactMary Guiney
Outcome results
None listed