Effect of Inflammation on Pharmacokinetics of Posaconazole
Study Details
Study Description
Brief Summary
Posaconazole plasma concentration and inflammatory markers will be determined in all samples available from routine analysis.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
posaconazole-group patients receiving posaconazole for prophylaxis or treatment of invasive fungal infection |
Drug: posaconazole
collection plasma samples for measuring posaconazole drug concentration
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 yrs
-
receiving posaconazole
-
Written informed consent
Exclusion Criteria:
- none
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University Medical Center Groningen | Groningen | Netherlands | 9700 RB |
Sponsors and Collaborators
- University Medical Center Groningen
Investigators
- Principal Investigator: Jan-Willem Alffenaar, PharmD, PhD, UMCG
Study Documents (Full-Text)
More Information
Publications
None provided.- POSA-CRP
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Patients on Posaconazole |
---|---|
Arm/Group Description | Hematology patients receiving posaconazole for routine care. |
Period Title: Overall Study | |
STARTED | 64 |
COMPLETED | 64 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | Patients on Posaconazole |
---|---|
Arm/Group Description | Patient characteristics and drug dosing information (oral and intravenous dosing, daily dose of posaconazole) |
Overall Participants | 64 |
Age (years) [Median (Inter-Quartile Range) ] | |
Median (Inter-Quartile Range) [years] |
62
|
Sex: Female, Male (Count of Participants) | |
Female |
23
35.9%
|
Male |
41
64.1%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
0
0%
|
White |
0
0%
|
More than one race |
0
0%
|
Unknown or Not Reported |
64
100%
|
Weight (kg) (kg) [Median (Inter-Quartile Range) ] | |
Median (Inter-Quartile Range) [kg] |
79
|
Height (cm) (cm) [Median (Inter-Quartile Range) ] | |
Median (Inter-Quartile Range) [cm] |
178
|
Acute myeloid leukemia (Count of Participants) | |
Count of Participants [Participants] |
40
62.5%
|
Myelodysplastic syndrome (Count of Participants) | |
Count of Participants [Participants] |
10
15.6%
|
Other underlying disease (Count of Participants) | |
Count of Participants [Participants] |
14
21.9%
|
Allogeneic stem cell transplant (Count of Participants) | |
Count of Participants [Participants] |
22
34.4%
|
Autologous stem cell transplant (Count of Participants) | |
Count of Participants [Participants] |
2
3.1%
|
No stem cell transplant received (Count of Participants) | |
Count of Participants [Participants] |
39
60.9%
|
Oral posaconazole (Count of Participants) | |
Count of Participants [Participants] |
59
92.2%
|
Intravenous and oral posaconazole (Count of Participants) | |
Count of Participants [Participants] |
5
7.8%
|
Daily dose of posaconazole (mg/kg) (mg/kg) [Median (Inter-Quartile Range) ] | |
Median (Inter-Quartile Range) [mg/kg] |
4.5
|
Both stem cell transplantations received (Count of Participants) | |
Count of Participants [Participants] |
1
1.6%
|
Outcome Measures
Title | C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Posaconazole |
---|---|
Arm/Group Description | Patients who received posaconazole for routine care |
Measure Participants | 64 |
Posaconazole concentration |
1.8
|
C reactive protein |
23.5
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Posaconazole |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.77 |
Comments | ||
Method | The Wald Type III test | |
Comments |
Adverse Events
Time Frame | Adverse events (AEs) were evaluated from the start of the treatment up to 1 year. | |
---|---|---|
Adverse Event Reporting Description | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term. | |
Arm/Group Title | Posaconazole | |
Arm/Group Description | Route of administration: Oral (MDR tablet), intravenous (infusion) Daily dose (mg/kg body weight): 3.75 (3.4-4.9) | |
All Cause Mortality |
||
Posaconazole | ||
Affected / at Risk (%) | # Events | |
Total | 5/64 (7.8%) | |
Serious Adverse Events |
||
Posaconazole | ||
Affected / at Risk (%) | # Events | |
Total | 0/64 (0%) | |
Other (Not Including Serious) Adverse Events |
||
Posaconazole | ||
Affected / at Risk (%) | # Events | |
Total | 3/64 (4.7%) | |
Blood and lymphatic system disorders | ||
Blood and lymphatic system disorders | 1/64 (1.6%) | 1 |
Blood and lymphatic system disorders | 1/64 (1.6%) | 1 |
Hepatobiliary disorders | ||
Hepatobiliary disorders | 1/64 (1.6%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Jan-Willem Alffenaar, PhD |
---|---|
Organization | University Medical Center Groningen |
Phone | +31503614035 |
j.w.c.alffenaar@umcg.nl |
- POSA-CRP