Table 2 Laboratory tests
Laboratory test | Sampling days | Measured parameters |
|---|---|---|
Hematology (3 ml blood sampling, local laboratory) | D0, every day of first week of treatment, D9, D11, D14 (EOT), D21, D28 (EOS) | Hb, hematocrit, WBC, RBC, platelets |
Biochemistry (3 ml blood sampling, local laboratory) | D0, every day of first week of treatment, D9, D11, D14 (EOT), D21, D28 (EOS) | Na, K, Ca, glucose, AST, ALT, alkaline phosphatases, total bilirubin, prothrombin time, albumin, serum creatinine |
Procalcitonin (local lab) | D0, D3, D7, D14 (EOT) | |
Urinalysis (local lab) | D0, D1, D7, D14 (EOT) | Proteins, creatinine |
Blood culture (10 ml blood sampling) | D0, D3, D7, D14 (EOT), D28 (EOS) | Analyses in the local laboratory, completed with further centralized analyses in case of positive results |
Mycological follow-up of colonization | D0 | Culture of specimens of mouth, throat, upper and lower respiratory tract, skin folds, urine and lower gastro-intestinal tract (rectal swab and feces), and if necessary drains, catheters and postoperative aspiration. In case of positive culture, an in vitro sensitivity study (E-test) to pre-defined antifungal agents is performed at inclusion on isolates |
Analyses in the local laboratory, completed with further centralized analyses in case of positive results | ||
Centralized microbiological analyses of blood samples and positive blood cultures (Mycology-Parasitology Departments of Grenoble and Rennes University Hospitals) | D0, D3, D7, D14, D28 | Biomarkers: blood PCR Candida analysis and (1–3)-β-D-glucan level, mannan antigen, anti-mannan antibodies tests if patient exhibits symptoms of invasive candidiasis |
In case of positive blood culture or deep sites: search for molecular resistance markers (biobank) | ||
PK sampling (5 ml blood sampling) | D0, D1 | Three samples following first study drug intake and two following the second intake. Sampling times specific to groups A and B |