Voriconazole Blood Level and Liver Metabolizing Enzyme in Taiwanese Patients

NCT00745992 | Completed

• 2 other identifiers: 200801019RNSC 97-2320-B-002 -016 -MY3
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Voriconazole is an effective antifungal agent and may decrease morbidity and mortality for patients with invasive fungal infections. It is metabolized via liver enzymes. However, these enzymes exhibit different activities in individual patient (genetic polymorphism). Higher proportions of Asians metabolize voriconazole slower than Caucasians and African Americans do. Slower metabolizers may experience dose-associated adverse events more frequently, such as visual disturbances, liver function test abnormalities, and neurological complications. On the other hand, extensive metabolizer or other physiologic conditions may lead to lower blood levels of voriconazole, which may result in treatment failure. We plan to enroll patient who take voriconazole and examine their liver enzyme activities and blood samples for peak and trough drug levels. We will collect potential factors affecting voriconazole levels, and correlate the levels with the dosing regimen, activity of liver enzyme, occurrence of adverse events, and treatment outcomes. The goal of this study is to determine if monitoring of voriconazole blood levels is necessary in Taiwan.

Conditions

Invasive Fungal Infections

Keywords

Voriconazole; Antifungal Agents; Invasive fungal infections; Therapeutic drug monitoring; CYP Genetic polymorphism

Outcome Measures

Primary Outcomes (1)

• Relationship between treatment outcome and voriconazole plasma levels

  continuous observation through treatment course

Secondary Outcomes (2)

• Relationship between voriconazole plasma levels and CYP2C19 polymorphism

  3-5 days after start of IV/PO voriconazole

• Relationship between safety and voriconazole plasma levels

  Continuous observation through treatment course

Study Arms (1)

Fungal infections

1. Patients with invasive fungal infections; and 2. Patients who receive PO or IV voriconazole for more than 3 days

Other: Blood drawn (lab data)

Interventions

Blood drawn (lab data) OTHER

1. Check drug blood level 3-5 days after start of drug, treatment failure, occurence of adverse events, or clinically indicated 2. Check genetic polymorphism of liver enzyme 3-5 days after start of drug

Also known as: Plasma concentration, Enzyme genetic polymorphism, SNP

Fungal infections

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospitalization patient or ambulatory patients, Patients with invasive fungal infections, Patients who take PO/IV voricoanzole more than 3 days

You may qualify if:

• Hospitalization patient or ambulatory patients
• Patients with invasive fungal infections
• Patients who take PO/IV voriconazole more than 3 days

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

• Bruggemann RJ, Donnelly JP, Aarnoutse RE, Warris A, Blijlevens NM, Mouton JW, Verweij PE, Burger DM. Therapeutic drug monitoring of voriconazole. Ther Drug Monit. 2008 Aug;30(4):403-11. doi: 10.1097/FTD.0b013e31817b1a95.

  PMID: 18641555 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Invasive Fungal Infections

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• Shu-Wen Lin, PharmD, MS

  Graduate Institute of Clinical Pharmacy, National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2008
• First Posted: September 3, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: February 10, 2022

Record last verified: 2008-09

Locations

TW (1)