Trial Outcomes & Findings for Effect of Inflammation on Pharmacokinetics of Posaconazole (NCT NCT02492802)
NCT ID: NCT02492802
Last Updated: 2019-08-06
Results Overview
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.
COMPLETED
64 participants
6 months after start of treatment
2019-08-06
Participant Flow
Participant milestones
| Measure |
Patients on Posaconazole
Hematology patients receiving posaconazole for routine care.
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
COMPLETED
|
64
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Inflammation on Pharmacokinetics of Posaconazole
Baseline characteristics by cohort
| Measure |
Patients on Posaconazole
n=64 Participants
Patient characteristics and drug dosing information (oral and intravenous dosing, daily dose of posaconazole)
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
64 Participants
n=5 Participants
|
|
Weight (kg)
|
79 kg
n=5 Participants
|
|
Height (cm)
|
178 cm
n=5 Participants
|
|
Acute myeloid leukemia
|
40 Participants
n=5 Participants
|
|
Myelodysplastic syndrome
|
10 Participants
n=5 Participants
|
|
Other underlying disease
|
14 Participants
n=5 Participants
|
|
Allogeneic stem cell transplant
|
22 Participants
n=5 Participants
|
|
Autologous stem cell transplant
|
2 Participants
n=5 Participants
|
|
No stem cell transplant received
|
39 Participants
n=5 Participants
|
|
Oral posaconazole
|
59 Participants
n=5 Participants
|
|
Intravenous and oral posaconazole
|
5 Participants
n=5 Participants
|
|
Daily dose of posaconazole (mg/kg)
|
4.5 mg/kg
n=5 Participants
|
|
Both stem cell transplantations received
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months after start of treatmentPosaconazole 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.
Outcome measures
| Measure |
Posaconazole
n=64 Participants
Patients who received posaconazole for routine care
|
|---|---|
|
C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L
C reactive protein
|
23.5 mg/L
Interval 5.0 to 75.0
|
|
C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L
Posaconazole concentration
|
1.8 mg/L
Interval 1.0 to 2.9
|
Adverse Events
Posaconazole
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Posaconazole
n=64 participants at risk
Route of administration:
Oral (MDR tablet), intravenous (infusion) Daily dose (mg/kg body weight): 3.75 (3.4-4.9)
|
|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
1.6%
1/64 • Number of events 1 • 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.
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
1.6%
1/64 • Number of events 1 • 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.
|
Additional Information
Jan-Willem Alffenaar, PhD
University Medical Center Groningen
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place