Effect of Inflammation on Voriconazole Concentration

NCT02074462

Last updated date
Study Location
University Medical Center Groningen
Groningen, , 9700 RB, Netherlands
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Inflammation, Fungal Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- age ≥ 18 yrs

- treatment with voriconazole

- written informed consent

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- concomitantly using a strong inhibitor or inducer of CYP P450

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Inflammation, Fungal InfectionEffect of Inflammation on Voriconazole Concentration
NCT02074462
  1. Groningen,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Effect of Inflammation on Voriconazole Concentration
Official Title Managing Voriconazole Exposure During Severe Infection; Effect of Inflammation on Voriconazole Metabolic Ratio
Brief Summary Voriconazole is a broad-spectrum antifungal agent. There is evidence for a relation between the efficacy and safety of voriconazole and voriconazole trough concentrations. There are several factors that could influence voriconazole concentrations. Inflammation could be one of these factors. In a retrospective study was observed that reduced metabolism of voriconazole was related to inflammation in patients with severe infections. Reduced metabolism of voriconazole resulted in high voriconazole levels and low N-oxide metabolite (inactive metabolite of voriconazole) levels. The purpose of this study is to determine an algorithm to guide dosing of voriconazole during severe inflammation and to develop a multiple linear regression model to describe the contribution of CRP concentrations to the variability in voriconazole levels and metabolic ratio.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood, serum
Sampling Method Probability Sample
Study Population All patients admitted to the University Medical Center Groningen who receive voriconazole
Condition
  • Inflammation
  • Fungal Infection
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 13, 2014)
36
Original Estimated Enrollment
 (submitted: February 26, 2014)
30
Actual Study Completion Date August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • age ? 18 yrs
  • treatment with voriconazole
  • written informed consent

Exclusion Criteria:

  • concomitantly using a strong inhibitor or inducer of CYP P450
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02074462
Other Study ID Numbers VCZ-13O30
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party JWC Alffenaar, University Medical Center Groningen
Study Sponsor University Medical Center Groningen
Collaborators Pfizer
Investigators Not Provided
PRS Account University Medical Center Groningen
Verification Date August 2014