Pharmacokinetics Clinical Trial
Official title:
Pharmacokinetic Study in Patients Receiving Posaconazole Therapy in Taiwan
The purpose of this study is to investigate the factors influencing pharmacokinetic and pharmacodynamic properties of new antifungal agent, posaconazole in Taiwanese patients.
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.
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Observational Model: Case-Only, Time Perspective: Prospective
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