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Pharmacokinetic Study in Patients Receiving Posaconazole Therapy in Taiwan

Pharmacokinetic Study in Patients Receiving Posaconazole Therapy in Taiwan

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02217761
Enrollment
400
Registered
2014-08-15
Start date
2012-03-31
Completion date
2017-07-31
Last updated
2014-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics, Posaconazole

Keywords

Pharmacokinetics, Antifungal Agents

Brief summary

The purpose of this study is to investigate the factors influencing pharmacokinetic and pharmacodynamic properties of new antifungal agent, posaconazole in Taiwanese patients.

Detailed description

Invasive fungal infection (IFI) may cause high mortality and morbidity in immune- compromised patients. Posaconazole, a new triazole antifungal agent with broad spectrum coverage, was approved for both treatment and prophylaxis of IFIs. Previous studies have demonstrated the relationship between posaconazole plasma concentration and efficacy, thus, the importance of posaconazole therapeutic drug monitoring (TDM) was gradually accepted. However, studies found inter- and intra-individual variation between concentrations, and these phenomenons were affected greatly by GI function, food intake and concomitant medication. Furthermore, there's a lack of posaconazole TDM study in Asian population. The study was designed to describe the prescribing pattern of posaconazole, to study the relationship between concentration and clinical outcomes/ adverse events, to identify factors that influence plasma concentration, and to evaluate whether routine TDM is needed in our institution.

Interventions

None listed

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients receiving posaconazole therapy * Patients aged 13 years old or more

Exclusion criteria

* No posaconazole plasma concentration available

Design outcomes

Primary

MeasureTime frame
Plasma posaconazole concentration7-10 days after taking posaconazole

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026