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NCT02217761 Clinical Trial

Pharmacokinetic Study in Patients Receiving Posaconazole Therapy in Taiwan

Pharmacokinetics Clinical Trial

Official title:
Pharmacokinetic Study in Patients Receiving Posaconazole Therapy in Taiwan

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02217761
Other study ID # 201112163RID
Secondary ID
Status Enrolling by invitation
Phase N/A
First received August 13, 2014
Last updated August 13, 2014
Start date March 2012
Est. completion date July 2017

Study information
Verified date August 2014
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

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

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 information / eligibility
Status Enrolling by invitation
Enrollment 400
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility Inclusion Criteria:

- Patients receiving posaconazole therapy

- Patients aged 13 years old or more

Exclusion Criteria:

- No posaconazole plasma concentration available

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma posaconazole concentration 7-10 days after taking posaconazole No
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