Therapeutic Drug MonitoringNCT05275179
Pharmacokinetic of Posaconazole in Critically Ill Patients
An observational study of Therapeutic Drug Monitoring and Critical Illness, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The posaconazole pharmacokinetic in critically ill patients will be studied in a prospective, non-interventional, monocentric observational trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Therapeutic Drug Monitoring, Critical Illness
- What is being tested?
- Posaconazole Therapeutic Drug Monitoring
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 11 Feb 2021to 1 Nov 2022
- 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: Critically ill patients treated with posaconazole intravenously.
Who may be able to join
- treatment with intravenous posaconazole
- critically ill patient
- written declaration of consent
Who cannot join
- no declaration of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic of Intravenous Posaconazole in Critically Ill Patients
The posaconazole pharmacokinetic in critically ill patients will be studied in a prospective, non-interventional, monocentric observational trial.
Read the detailed description
The posaconazole pharmacokinetic in critically ill patients will be studied in a prospective, non-interventional, monocentric observational trial. Plasma specimens will be retrieved on consecutive days (max. 7 days) in order to measure posaconazole levels during the treatment episode.
- Conditions
- Therapeutic Drug Monitoring, Critical Illness
- Being tested
- Posaconazole Therapeutic Drug Monitoring
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posaconazole Therapeutic Drug MonitoringOther
Therapeutic Drug Monitoring is performed by measuring posaconazole concentrations in serum on seven consecutive days (anticipated).
| Study group | Role | What they receive |
|---|---|---|
| Posaconazole Therapeutic Drug Monitoring | Therapeutic Drug Monitoring of posaconzole is performed by measuring posaconazole concentrations in serum Receives: Other: Posaconazole Therapeutic Drug Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posaconazole Drug Exposure
Measurement of posaconazole concentration in serum
Measured: seven days from therapystart
Secondary outcomes (3)
population-pharmacokinetic analysis 1
Analysis of Peak Plasma Concentration (Cmax) for posaconazole in the given cohort.
Measured: 12 months after close out
population-pharmacokinetic analysis 2
Analysis of Area under the plasma concentration versus time curve (AUC) for posaconazole in the given cohort.
Measured: 12 months after close out
Evaluation of probability of target attainment of posaconazole
Analysis of Monte-Carlo-Simulations in order to asses novel dosing regimens for posaconazole.
Measured: 12 months after close out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start11 Feb 2021
- Primary completion30 Mar 2022
- Study completion1 Nov 2022
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 Therapeutic Drug MonitoringStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominic Wichmann, Prof, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275179
- Sponsor's protocol ID
- PV7263
- Status last verified
- Nov 2022
- First submitted
- 21 Jan 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Konig C, Gopfert M, Kluge S, Wichmann D. Posaconazole exposure in critically ill ICU patients: a need for action. Infection. 2023 Dec;51(6):1767-1772. doi: 10.1007/s15010-023-02078-9. Epub 2023 Jul 27.
PubMed 37498488
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic of Intravenous Posaconazole in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT05275179
- Acronym / sponsor ID
- PV7263
- Conditions
- Therapeutic Drug Monitoring, Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 11 Mar 2022 (actual)
- 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.
The posaconazole pharmacokinetic in critically ill patients will be studied in a prospective, non-interventional, monocentric observational trial.
Detailed description
The posaconazole pharmacokinetic in critically ill patients will be studied in a prospective, non-interventional, monocentric observational trial. Plasma specimens will be retrieved on consecutive days (max. 7 days) in order to measure posaconazole levels during the treatment episode.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Posaconazole Therapeutic Drug Monitoring | – | Other: Posaconazole Therapeutic Drug MonitoringTherapeutic Drug Monitoring of posaconzole is performed by measuring posaconazole concentrations in serum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients treated with posaconazole intravenously.
Key inclusion criteria (3 listed)
- treatment with intravenous posaconazole
- critically ill patient
- written declaration of consent
Key exclusion criteria (1 listed)
- no declaration of consent
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 |
|---|---|---|
| Posaconazole Therapeutic Drug MonitoringTherapeutic Drug Monitoring is performed by measuring posaconazole concentrations in serum on seven consecutive days (anticipated). | Other | Posaconazole Therapeutic Drug Monitoring |
Primary outcome
Posaconazole Drug Exposure
Time frame: seven days from therapystart
Measurement of posaconazole concentration in serum
3 secondary outcomes
population-pharmacokinetic analysis 1
Time frame: 12 months after close out
population-pharmacokinetic analysis 2
Time frame: 12 months after close out
Evaluation of probability of target attainment of posaconazole
Time frame: 12 months after close out
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 8 Nov 2022.
- Derived from this study: PubMed 37498488Konig C, Gopfert M, Kluge S, Wichmann D. Posaconazole exposure in critically ill ICU patients: a need for action. Infection. 2023 Dec;51(6):1767-1772. doi: 10.1007/s15010-023-02078-9. Epub 2023 Jul 27.
- Individual participant dataSharing planned: No
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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.
Dominic Wichmann, Prof principal investigator
Universitätsklinikum Hamburg-Eppendorf
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 Therapeutic Drug Monitoring and Critical Illness, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 8 Nov 2022. 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 Germany. 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?
Posaconazole Drug Exposure (time frame: seven days from therapystart). 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 NCT05275179, 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 8 Nov 2022.