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Pharmacokinetic Study in Patients Receiving Posaconazole Therapy in Taiwan

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National Taiwan University

Status

Unknown

Conditions

Posaconazole
Pharmacokinetics

Study type

Observational

Funder types

Other

Identifiers

NCT02217761
201112163RID

Details and patient eligibility

About

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

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • No posaconazole plasma concentration available

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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