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Posaconazole plasma concentration and inflammatory markers will be determined in all samples available from routine analysis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| posaconazole-group | patients receiving posaconazole for prophylaxis or treatment of invasive fungal infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| posaconazole | Drug | collection plasma samples for measuring posaconazole drug concentration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after start of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan-Willem Alffenaar, PharmD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | 9700 RB | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients on Posaconazole | Hematology patients receiving posaconazole for routine care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients on Posaconazole | Patient characteristics and drug dosing information (oral and intravenous dosing, daily dose of posaconazole) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | mg/L | 6 months after start of treatment |
|
|
Adverse events (AEs) were evaluated from the start of the treatment up to 1 year.
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Posaconazole | Route of administration: Oral (MDR tablet), intravenous (infusion) Daily dose (mg/kg body weight): 3.75 (3.4-4.9) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Non-systematic Assessment | Thrombocytes and leukocytes levels decreased after starting posaconazole, however another drug could have also caused that adverse event (cotrimoxazole). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jan-Willem Alffenaar, PhD | University Medical Center Groningen | +31503614035 | j.w.c.alffenaar@umcg.nl |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2015 | Feb 6, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C101425 | posaconazole |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight (kg) | Median | Inter-Quartile Range | kg |
|
| Height (cm) | Median | Inter-Quartile Range | cm |
|
| Acute myeloid leukemia | Count of Participants | Participants |
|
| Myelodysplastic syndrome | Count of Participants | Participants |
|
| Other underlying disease | Count of Participants | Participants |
|
| Allogeneic stem cell transplant | Count of Participants | Participants |
|
| Autologous stem cell transplant | Count of Participants | Participants |
|
| No stem cell transplant received | Count of Participants | Participants |
|
| Oral posaconazole | Count of Participants | Participants |
|
| Intravenous and oral posaconazole | Count of Participants | Participants |
|
| Daily dose of posaconazole (mg/kg) | Median | Inter-Quartile Range | mg/kg |
|
| Both stem cell transplantations received | Count of Participants | Participants |
|
| Participants |
|
|
|
| 5 |
| 64 |
| 0 |
| 64 |
| 3 |
| 64 |
|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Non-systematic Assessment | Patient had hypernatremia after starting posaconazole, calcium and potassium were normal and another alternative cause was diagnosed diabetes insipidus. |
|
| Hepatobiliary disorders | Hepatobiliary disorders | Non-systematic Assessment | After starting posaconazole there was a slight increase in liver enzymes (ALAT, ASAT). |
|
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