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
• 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

• Pharmacokinetics
• Posaconazole

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