Antifungal resistance in Candida among ICU patients Infections and Infestations
Conditions
Interventions
Current interventions as of 08/05/2025:
Participants will undergo:
- twice weekly oral/perianal skin swab for Candida spp.
- 7 blood draws from CVC at 0 h, 6 h, 12 h, 24 h, 36 h, 48 h, 72 h, and D7 f
BDG/ BDG/Candida PCR D14 and D21 (total volume: 6ml above standard of care)
- urine sampling at 0 h, 24 h,72 h and D7 for fungal culture, If drain in situ: drain fluid sampling (10 ml) at 0 h, 6 h, 12
Sponsors
St George’s University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 10/07/2025: 1. Age =18 years 2. Suspected or confirmed invasive candidiasis _____ Previous inclusion criteria as of 12/11/2024: 1. Age =18 years 2. Currently receiving intravenous antibiotics 3. One or more of the following Candida risk factors: 3.1. Abdominal surgery in the last 4 weeks 3.2. Upper gastrointestinal/mediastinal perforation or surgery in the last 4 weeks 3.3. Liver failure 3.4. Haematological malignancy 3.5. Previous bone marrow or solid organ transplant 3.6. Neutropenia (neutrophils < 0.5*10e9/l) 3.7. Receipt of an immunosuppressive drug (including corticosteroids, chemotherapy, immune-modulators) 3.8. Total parenteral nutrition (TPN) 3.9. Renal replacement therapy 3.10. Extracorporeal membrane oxygenation (ECMO) 4. Suspected or confirmed invasive candidiasis _____ Previous inclusion criteria: 1. Age =18 years 2. Currently receiving intravenous antibiotics 3. One or more of the following Candida risk factors: 3.1. Abdominal surgery in the last 4 weeks 3.2. Upper gastrointestinal/mediastinal perforation or surgery in the last 4 weeks 3.3. Liver failure 3.4. Haematological malignancy 3.5. Previous bone marrow or solid organ transplant 3.6. Neutropenia (neutrophils < 0.5*10e9/l) 3.7. Receipt of an immunosuppressive drug (including corticosteroids, chemotherapy, immune-modulators) 3.8. Total parenteral nutrition (TPN) 3.9. Renal replacement therapy 3.10. Extracorporeal membrane oxygenation (ECMO) 4. Suspected invasive candidiasis (added 25/08/2023)
Exclusion criteria
Exclusion criteria: Expected ICU length of stay <48 h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 10/07/2025: Incidence rate of colonisation and invasive infection with azole or echinocandin-resistant Candida spp. in those exposed or not exposed to an antifungal during their ICU stay. Change in isolate MIC and supra-MIC growth (tolerance). Previous primary outcome measure: Colonisation and invasive infection with azole or echinocandin-resistant Candida spp. (e.g. C. glabrata; C. parapsilosis; C. auris) measured using MALDI-ToF mass spectrometry and resistance profiling at the end of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at end of follow-up unless otherwise noted: 1. Invasive candidiasis, rationale and duration of antifungal therapy, measured using EORTC diagnostic classification at the end of follow-up 2. Isolate antifungal tolerance, measured using change in isolate MIC and supra-MIC growth measured according to CLSI standards at end of follow-up 3. Emergence of genetic mutations associated with antifungal resistance, measured using genetic analysis at end of follow-up 4. Mycological clearance in candidaemic patients treated with antifungals, measured using rate of decline in CFU/BDG/time-to-culture-positivity at 12 h, 24 h, 36 h, 48 h, 72 h and D7 from diagnosis of candidaemia. 5. Exploratory: relationship between Candida resistance phenotype and genotype, PK and PD in candidaemia, measured using MIC, tolerance, antifungal drug levels and mycological clearance at 12 h, 24 h, 36 h, 48 h, 72 h and D7 from diagnosis of candidaemia 6. In-hospital mortality measured using patient records at end of follow-up Added 10/07/2025: 7. Stool sample for faecal mycobiome analysis on days 1, 7 and 14 | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed