MycosesNCT02492802
Effect of Inflammation on Pharmacokinetics of Posaconazole
An observational study of Mycoses, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Posaconazole plasma concentration and inflammatory markers will be determined in all samples available from routine analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycoses
- What is being tested?
- posaconazole
- How many people
- 64 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Aug 2015to 1 Aug 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: * patients with hematological malignancies * immunocompromised patients
Who may be able to join
- >18 yrs
- receiving posaconazole
- Written informed consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Posaconazole plasma concentration and inflammatory markers will be determined in all samples available from routine analysis.
Read the detailed description
A prospective observational study will be performed at the University Medical Center Groningen, the Netherlands using longitudinal data collection. The design of the study will be that patients starting on posaconazole treatment will be evaluated. After informed consent is obtained medical data will be collected from the medical chart. Posaconazole plasma concentration (trough levels) and inflammatory markers (e.g. C-reactive protein) will be determined in all samples available from routine analysis (often daily). This will result in a detailed data set capturing day to day variations in inflammation and drug concentrations.
- Conditions
- Mycoses
- Being tested
- posaconazole
- Medical subject headings
- Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posaconazoleDrug
Also called noxafil
collection plasma samples for measuring posaconazole drug concentration
| Study group | Role | What they receive |
|---|---|---|
| posaconazole-group | patients receiving posaconazole for prophylaxis or treatment of invasive fungal infection Receives: Drug: posaconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L
Posaconazole drug exposure during treatment in different stages of inflammation. To determine the differences in concentrations between patients a random additive effect was used. Additionally, to correct for differences in intervals between observations a first-order autoregressive correlation was used. The Wald type III test was used to assess the influence of inflammation on posaconazole concentration.
Measured: 6 months after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study start13 Aug 2015
- Primary completion1 Jun 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MycosesStudies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan-Willem C Alffenaar, University Medical Center Groningen
- Investigators
- Jan-Willem Alffenaar, PharmD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492802
- Sponsor's protocol ID
- POSA-CRP
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2015
- Last updated
- 6 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inflammation on Pharmacokinetics of Posaconazole
- ClinicalTrials.gov ID
- NCT02492802
- Acronym / sponsor ID
- POSA-CRP
- Conditions
- Mycoses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 13 Aug 2015 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Posted 7 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Posaconazole plasma concentration and inflammatory markers will be determined in all samples available from routine analysis.
Detailed description
A prospective observational study will be performed at the University Medical Center Groningen, the Netherlands using longitudinal data collection. The design of the study will be that patients starting on posaconazole treatment will be evaluated. After informed consent is obtained medical data will be collected from the medical chart. Posaconazole plasma concentration (trough levels) and inflammatory markers (e.g. C-reactive protein) will be determined in all samples available from routine analysis (often daily). This will result in a detailed data set capturing day to day variations in inflammation and drug concentrations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| posaconazole-group | – | Drug: posaconazolepatients receiving posaconazole for prophylaxis or treatment of invasive fungal infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * patients with hematological malignancies * immunocompromised patients
Key inclusion criteria (3 listed)
- >18 yrs
- receiving posaconazole
- Written informed consent
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| posaconazoleAlso: noxafilcollection plasma samples for measuring posaconazole drug concentration | Drug | posaconazole-group |
Primary outcome
C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L
Time frame: 6 months after start of treatment
Posaconazole drug exposure during treatment in different stages of inflammation. To determine the differences in concentrations between patients a random additive effect was used. Additionally, to correct for differences in intervals between observations a first-order autoregressive correlation was used. The Wald type III test was used to assess the influence of inflammation on posaconazole concentration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jan-Willem Alffenaar, PharmD, PhD principal investigator
University Medical Center Groningen
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 Mycoses, 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 6 Aug 2019. 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?
Yes. Results are posted in the registry (first posted 7 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L (time frame: 6 months after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2019.