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Pharmacokinetic Study in Patients Receiving Posaconazole Therapy in Taiwan

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02217761
Collaborator
(none)
400
Enrollment
64
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Pharmacokinetic Study in Patients Receiving Posaconazole Therapy in Taiwan
    Study Start Date :
    Mar 1, 2012
    Anticipated Primary Completion Date :
    Jul 1, 2017
    Anticipated Study Completion Date :
    Jul 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Plasma posaconazole concentration [7-10 days after taking posaconazole]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients receiving posaconazole therapy

    • Patients aged 13 years old or more

    Exclusion Criteria:
    • No posaconazole plasma concentration available

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Shu-Wen Lin, Pharm. D., Graduate institute of clinical pharmacy at National Taiwan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT02217761
    Other Study ID Numbers:
    • 201112163RID
    First Posted:
    Aug 15, 2014
    Last Update Posted:
    Aug 15, 2014
    Last Verified:
    Aug 1, 2014
    Keywords provided by National Taiwan University Hospital
    Pharmacokinetics
    Antifungal Agents

    Study Results

    No Results Posted as of Aug 15, 2014