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NCT02492802

Effect of Inflammation on Pharmacokinetics of Posaconazole

Completed Results posted Last updated 6 August 2019
What this trial tests

trial testing posaconazole in Mycoses in 64 participants. Completed in 1 August 2017.

Timeline
13 August 2015
Primary endpoint
1 June 2017
1 August 2017

Quick facts

Lead sponsorUniversity Medical Center Groningen
StatusCompleted
Study typeOBSERVATIONAL
Enrollment64
Start date13 August 2015
Primary completion1 June 2017
Estimated completion1 August 2017
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

University Medical Center Groningen

Who can join

18 and older, any sex, with Mycoses. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L Primary · 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.

Posaconazole concentration
GroupValue95% CI
Posaconazole1.81 – 2.9
C reactive protein
GroupValue95% CI
Posaconazole23.55 – 75

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events (AEs) were evaluated from the start of the treatment up to 1 year.. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Posaconazole
Serious: 0/64 (0%)
Deaths: 5/64
Other adverse events (3 terms — click to expand)

ReactionSystemPosaconazole
Blood and lymphatic system disordersBlood and lymphatic system disorders
Blood and lymphatic system disordersBlood and lymphatic system disorders
Hepatobiliary disordersHepatobiliary disorders

Data from ClinicalTrials.gov NCT02492802 adverse events section.

Sponsor's own description

Posaconazole plasma concentration and inflammatory markers will be determined in all samples available from routine analysis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of posaconazole

Trials testing the same drug.

Other University Medical Center Groningen trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02492802.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing