InflammationNCT02074462
Effect of Inflammation on Voriconazole Concentration
An observational study of Inflammation and Fungal Infection, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Fungal Infection
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2014to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to the University Medical Center Groningen who receive voriconazole
Who may be able to join
- age ≥ 18 yrs
- treatment with voriconazole
- written informed consent
Who cannot join
- concomitantly using a strong inhibitor or inducer of CYP P450
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Managing Voriconazole Exposure During Severe Infection; Effect of Inflammation on Voriconazole Metabolic Ratio
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.
- Conditions
- Inflammation, Fungal Infection
- Keywords
- Voriconazole, CRP, Inflammation, Pharmacokinetics
- Medical subject headings
- Inflammation, Mycoses
What is being measured
The primary outcome is the main question the study is designed to answer.
Plamsa concentration of voriconazole and voriconazole N-oxide in patients during a severe inflammation
Plasma concentrations of voriconazole and voriconazole N-oxide will be determined using a validated method involving LC-MS/MS
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, JWC Alffenaar, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074462
- Sponsor's protocol ID
- VCZ-13O30
- Status last verified
- Aug 2014
- First submitted
- 12 Feb 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Klomp SD, Veringa A, Alffenaar JC, de Boer MGJ, Span LFR, Guchelaar HJ, Swen JJ. Inflammation altered correlation between CYP2C19 genotype and CYP2C19 activity in patients receiving voriconazole. Clin Transl Sci. 2024 Jul;17(7):e13887. doi: 10.1111/cts.13887.
PubMed 39010708
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Voriconazole Exposure During Severe Infection; Effect of Inflammation on Voriconazole Metabolic Ratio
- ClinicalTrials.gov ID
- NCT02074462
- Acronym / sponsor ID
- VCZ-13O30
- Conditions
- Inflammation, Fungal Infection
- Keywords
- Voriconazole, CRP, Inflammation, Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 28 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the University Medical Center Groningen who receive voriconazole
Key inclusion criteria (3 listed)
- age ≥ 18 yrs
- treatment with voriconazole
- written informed consent
Key exclusion criteria (1 listed)
- concomitantly using a strong inhibitor or inducer of CYP P450
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plamsa concentration of voriconazole and voriconazole N-oxide in patients during a severe inflammation
Time frame: Up to 1 month
Plasma concentrations of voriconazole and voriconazole N-oxide will be determined using a validated method involving LC-MS/MS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- Derived from this study: PubMed 39010708Klomp SD, Veringa A, Alffenaar JC, de Boer MGJ, Span LFR, Guchelaar HJ, Swen JJ. Inflammation altered correlation between CYP2C19 genotype and CYP2C19 activity in patients receiving voriconazole. Clin Transl Sci. 2024 Jul;17(7):e13887. doi: 10.1111/cts.13887.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Fungal Infection, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plamsa concentration of voriconazole and voriconazole N-oxide in patients during a severe inflammation (time frame: Up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02074462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2014.