Pharmacokinetic Study in Patients Receiving Posaconazole Therapy in Taiwan
- Conditions
- PharmacokineticsPosaconazole
- Registration Number
- NCT02217761
- Lead Sponsor
- National Taiwan University Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
- Patients receiving posaconazole therapy
- Patients aged 13 years old or more
- No posaconazole plasma concentration available
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma posaconazole concentration 7-10 days after taking posaconazole
- Secondary Outcome Measures
Name Time Method