Mycoses
Conditions
Brief summary
Posaconazole plasma concentration and inflammatory markers will be determined in all samples available from routine analysis.
Detailed description
A prospective observational study will be performed at the University Medical Center Groningen, the Netherlands using longitudinal data collection. The design of the study will be that patients starting on posaconazole treatment will be evaluated. After informed consent is obtained medical data will be collected from the medical chart. Posaconazole plasma concentration (trough levels) and inflammatory markers (e.g. C-reactive protein) will be determined in all samples available from routine analysis (often daily). This will result in a detailed data set capturing day to day variations in inflammation and drug concentrations.
Interventions
DRUGposaconazole
collection plasma samples for measuring posaconazole drug concentration
Sponsors
University Medical Center Groningen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>18 yrs * receiving posaconazole * Written informed consent
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L | 6 months after start of treatment | Posaconazole drug exposure during treatment in different stages of inflammation. To determine the differences in concentrations between patients a random additive effect was used. Additionally, to correct for differences in intervals between observations a first-order autoregressive correlation was used. The Wald type III test was used to assess the influence of inflammation on posaconazole concentration. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients on Posaconazole Patient characteristics and drug dosing information (oral and intravenous dosing, daily dose of posaconazole) | 64 |
| Total | 64 |
Baseline characteristics
| Characteristic | Patients on Posaconazole |
|---|---|
| Acute myeloid leukemia | 40 Participants |
| Age, Continuous | 62 years |
| Allogeneic stem cell transplant | 22 Participants |
| Autologous stem cell transplant | 2 Participants |
| Both stem cell transplantations received | 1 Participants |
| Daily dose of posaconazole (mg/kg) | 4.5 mg/kg |
| Height (cm) | 178 cm |
| Intravenous and oral posaconazole | 5 Participants |
| Myelodysplastic syndrome | 10 Participants |
| No stem cell transplant received | 39 Participants |
| Oral posaconazole | 59 Participants |
| Other underlying disease | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 64 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 41 Participants |
| Weight (kg) | 79 kg |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 64 |
| other Total, other adverse events | 3 / 64 |
| serious Total, serious adverse events | 0 / 64 |
Outcome results
Primary
C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L
Posaconazole drug exposure during treatment in different stages of inflammation. To determine the differences in concentrations between patients a random additive effect was used. Additionally, to correct for differences in intervals between observations a first-order autoregressive correlation was used. The Wald type III test was used to assess the influence of inflammation on posaconazole concentration.
Time frame: 6 months after start of treatment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Posaconazole | C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L | Posaconazole concentration | 1.8 mg/L |
| Posaconazole | C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L | C reactive protein | 23.5 mg/L |
p-value: 0.77The Wald Type III test