The Study of Voriconazole Trough Level in the First Two Weeks After Administration in King Chulalongkorn Memorial Hospital.

August 21, 2017 updated by: Chulalongkorn University

Invasive fungal infections are a significant cause of morbidity and mortality in immunocompromised host such as prolong neutropenic patients , post transplantation patients, malignancies or advanced AIDS . The majority of these infections were caused by Aspergillus species, which the first line of treatment is antifungal agent, Voriconazole , a triazole antifungal drug which was approved by the Food and Drug Administration in May 2002 for the treatment of invasive aspergillosis and refractory infections of Scedosporium apiospermum and Fusarium spp. There are two forms of Voriconazole , oral and intravenous form. The recommendation dose is 6 mg/kg twice daily for two dosages, followed by 4 mg/kg twice daily in intravenous form or a loading dose of 400 mg twice daily for two doses is used (for individuals >40 kg), followed by 200 mg twice daily, and in individuals <40 kg the maintenance dose is 100 mg twice daily in oral form.

Voriconazole has a narrow therapeutic window and nonlinear pharmacokinetic profile with wide inter-individual and intra-individual variability, such as age, race, genotypic variation, liver dysfunction, the presence of food and drug-drug interactions with CYP450 inhibitors. These large variations in pharmacokinetics may be associated with decreased efficacy or increased toxicity. Therefore , monitoring of serum trough concentrations is recommended in the following infections: invasive aspergillosis treatment , endophthalmitis; meningitis or osteoarticular infections due to Exserohilum rostratum.

In Thai population , there are different genetic polymorphism from Caucasian ,resulting in a different response to the initial dose and there is limited resources in Thailand , mostly patients are unaccessible for Voriconazole level. Especially,in the period of starting drug, which is the critical period for patients ,most of them are post chemotherapy which may have gastrointestinal problems, mucositis , vomiting or diarrhea ,as well as receiving multiple concurrent medications. All of these affect drug absorption,drug level and efficacy of treatment. Thus, this study was designed to evaluated Voriconazole level in Thai patients in the first two week after administration.

Primary question

  • From the first collected of Voriconazole drug level , Are the invasive fungal infection patients in King Chulalongkorn Memorial Hospital achieved the drug level more than 60% ?

Secondary question

  • Which factor affecting Voriconazole through level in the first two weeks after administration?

Research Design

  • Observational Studies (Descriptive retrospective and prospective study)

Research Methodology

Target Population

  • Patients received Voriconazole for treatment or prophylaxis invasive fungal infection

Study population

  • Patients in King Chulalongkorn Memorial hospital received Voriconazole for treatment or prophylaxis invasive fungal infection

Sample size

n= ZZ/2P(1-P) /dd

  • n = sample size
  • P =Incident rate
  • From the pilot study of 15 Invasive fungal infection patients in King Chulalongkorn memorial hospital from February to September 2015 , 60% ( 9 of 15 patients) of the first collected of Voriconazole trough level achieved the therapeutic level.

replaced P = 0.6

  • Z = 95% confident interval = 1.96
  • d = acceptable error = 0.10

n = (1.96) (1.96) (0.60)(1-0.60) / (0.10)(0.10)

n =92 , sample size = 92

Study processing and data collection

Data collection

  • Collected data of patients received Voriconazole in first two weeks of treatment or prophylaxis invasive fungal infection in King Chulalongkorn Memorial hospital in 2015-2017 from outpatient records , inpatient records and computer database in King Chulalongkorn Memorial hospital. This data included
  • Baseline characteristics : sex, age ,weight ,BMI ,co-morbid ,personal history of smoking or alcohol drinking
  • Basic laboratory investigation : complete blood count , Creatinin , liver function test , albumin level
  • Gastrointestinal problems
  • Indication of Voriconazole treatment
  • Data of invasive fungal infection :
  • Data of Voriconazole usage : Loading dose, Maintenance dose, Trough level , Data of drug adjustment, Concurrent medication used, Side effect
  • All data was summarized and recorded in case report forms.

Data Analysis and Statistics

The data was analysed by computer using SPSS17 program This study used descriptive statistics ,describing general information, age, results, laboratory results and side effects of the drug in mean ,percentage or standard deviation. And used the chi-square test for analysis of the proportion of patients with serum drug levels within the therapeutic range.

This study used a confidence level of 95%, p-value less than 0.05 was statistically significant.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Thai patient in King Chulalongkorn Memorial Hospital ,Bangkok , Thailand, age between 18 and 80 year olds ,receiving Voriconazole for treatment or prophylaxis invasive fungal infection , between 2015-2017.

Description

Inclusion Criteria:

  • Thai patient in King Chulalongkorn Memorial Hospital , age between 18 and 80 years old
  • Receiving Voriconazole for treatment or prophylaxis invasive fungal infection

Exclusion Criteria:

  • Severe hepatic or renal dysfunction
  • Pregnancy
  • Presence of history of allergy to any Azole antifungal agents
  • Death within 2 weeks after treatment of invasive fungal infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Voriconazole

Patient was received voriconazole according to individual indication. The starting dose is 6 mg/kg iv twice daily for two dosages, followed by 4 mg/kg iv twice daily in intravenous form or a loading dose of 400 mg twice daily for two doses is used (for individuals >40 kg), followed by 200 mg twice daily, and in individuals <40 kg the maintenance dose is 100 mg twice daily in oral form.

The dosage was adjusted by drug level and toxicity. The duration of drug used was depended on indication of treatment.
Drug: Voriconazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients achieved therapeutic level of voriconazole in the first two weeks after administration
Time Frame: 2015-2017
2015-2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors have significant impact to voriconazole through level .
Time Frame: 2015-2017
Factors that have significant impact to voriconazole through level will be assess in this study such as drug interaction , oral mucositis .
2015-2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

August 8, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Actual)

August 24, 2017

Last Update Submitted That Met QC Criteria

August 21, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 496-59

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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