Invasive fungal diseases (invasive aspergillosis and invasive mucormycosis) involving the lung or the central nervous system.
Conditions
Interventions
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Chinese adult patients (>=18 years old); 2. Patients with confirmed IFD involving the lung or/and central nervous system, or those with a clinical diagnosis of IFD with at least one microbiological evidences; 3. Patients receiving isavuconazole, and the decision to use isavuconazole is made prior to and independently of study participation; 4. Patients with therapeutic needs to cerebrospinal fluid examination or bronchoalveolar lavage due to their condition with remaining samples available; 5. Patient or their legal representative voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients receiving antifungal medications (IA or IM) within the past 7 days and whose condition significantly improved; 2. Patients who cannot be treated with isavuconazole for contraindications as per isavuconazole label or by judgement of attending physicians/investigators; 3. Patients with unavailable simultaneous blood TDM and drug concentrations in cerebrospinal fluid or bronchoalveolar lavage fluid; 4. Patients with unavailable or incomplete prescription and administration information and sampling records; 5. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| minimum concentrations in serum, BALF, and CSF; | — |
Secondary
| Measure | Time frame |
|---|---|
| maximum concentrations in serum, BALF, and CSF;Proportion of patients with adverse events leading to treatment discontinuation;clinical response (treatment success or failure);overall response (treatment success or failure);Incidence of adverse events with possible reasons related to drug;Ratios of concentrations in BALF, AM, and CSF to those in serum;all-cause mortality;AUCs of serum, BALF, and CSF for 0-inf and 0-24 hours;Ratios of AUCs in BALF, AM, and CSF to those in serum;apparent clearance;apparent volume of distribution;average concentrations in serum, BALF, and CSF;times to peak concentration for serum, BALF, and CSF;Incidence of severe adverse events;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactJing Zhang
Huashan Hospital, Fudan University
Outcome results
None listed