Antibiotic PharmacokineticsNCT05134298
Pharmacokinetics of Piperacillin and Meropenem in ICU Patients
An observational study of Antibiotic Pharmacokinetics, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The purpose of the study is to characterize the pharmacokinetics of meropenem and piperacillin in ICU-patients at the time of the first dose administration and to contrast that with the same measurements obtained in the same patient 2-3 days later during the course of ICU treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic Pharmacokinetics
- What is being tested?
- Piperacillin/tazobactam, Meropenem
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2019to 31 Dec 2023
- 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: ICU-patients.
Who may be able to join
- Patient being treated in one of the participating ICUs and planned to recieve treatment with meropenem or piperacillin.
- Exclusion Criteria (fullfilling any exlusion criteria means that patient cannot be included in the study):
- Not possible to retrospectively ask the patient or next of kin for consent to take part in the study or patient or next-of-kin not providing consent.
- Not posisble to obtain and process blood samples as specified by protocol.
- Ongoing renal replacement therapy.
- Patient having received the same antibiotic within the previous 96 h.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 17176
Johan Petersson, MD, johan.petersson@sll.se
About this study
Official title: First Dose Pharmacokinetics for Piperacillin and Meropenem in ICU Patients
The purpose of the study is to characterize the pharmacokinetics of meropenem and piperacillin in ICU-patients at the time of the first dose administration and to contrast that with the same measurements obtained in the same patient 2-3 days later during the course of ICU treatment.
- Conditions
- Antibiotic Pharmacokinetics
- Being tested
- Piperacillin/tazobactam, Meropenem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin/tazobactam, MeropenemDrug
This is an observational study exploring the antibiotic plasma concentration profiles in ICU paitents after the first drug administration.
| Study group | Role | What they receive |
|---|---|---|
| Study Kohort | As specified by study population, inclusion and exclusion criteria Receives: Drug: Piperacillin/tazobactam, Meropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of distribution
Apparent volume of distribution calculated from repeated plasma concentrations measurements and pharmacokinetic modelling.
Measured: For the first antibiotic administration and if possible for a second administration 48-72 hour later.
Plasma clearance
Plasma clearance calculated from repeated plasma concentrations measurements and pharmacokinetic modelling.
Measured: For the first antibiotic administration and if possible for a second administration 48-72 hour later.
Secondary outcomes (1)
Plasma antibiotic concentrations at mid and end of dosing interval
Plasma antibiotic concentrations at mid and end of dosing interval
Measured: For the first antibiotic administration and if possible for a second administration 48-72 hour later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Nov 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic PharmacokineticsStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Petersson, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134298
- Sponsor's protocol ID
- K 2018-6443
- Status last verified
- Nov 2021
- First submitted
- 28 Oct 2019
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Dose Pharmacokinetics for Piperacillin and Meropenem in ICU Patients
- ClinicalTrials.gov ID
- NCT05134298
- Acronym / sponsor ID
- K 2018-6443
- Conditions
- Antibiotic Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Nov 2021 (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 purpose of the study is to characterize the pharmacokinetics of meropenem and piperacillin in ICU-patients at the time of the first dose administration and to contrast that with the same measurements obtained in the same patient 2-3 days later during the course of ICU treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Kohort | – | Drug: Piperacillin/tazobactam, MeropenemAs specified by study population, inclusion and exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU-patients.
Key inclusion criteria (6 listed)
- Patient being treated in one of the participating ICUs and planned to recieve treatment with meropenem or piperacillin.
- Exclusion Criteria (fullfilling any exlusion criteria means that patient cannot be included in the study):
- Not possible to retrospectively ask the patient or next of kin for consent to take part in the study or patient or next-of-kin not providing consent.
- Not posisble to obtain and process blood samples as specified by protocol.
- Ongoing renal replacement therapy.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Piperacillin/tazobactam, MeropenemThis is an observational study exploring the antibiotic plasma concentration profiles in ICU paitents after the first drug administration. | Drug | Study Kohort |
Primary outcome
Volume of distribution
Time frame: For the first antibiotic administration and if possible for a second administration 48-72 hour later.
Apparent volume of distribution calculated from repeated plasma concentrations measurements and pharmacokinetic modelling.
Plasma clearance
Time frame: For the first antibiotic administration and if possible for a second administration 48-72 hour later.
Plasma clearance calculated from repeated plasma concentrations measurements and pharmacokinetic modelling.
1 secondary outcome
Plasma antibiotic concentrations at mid and end of dosing interval
Time frame: For the first antibiotic administration and if possible for a second administration 48-72 hour later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 Antibiotic Pharmacokinetics, run by Karolinska University Hospital at 1 site in Sweden.
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 6 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 24 Nov 2021. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johan Petersson, MD, Ass Prof (+46-8-51770000, johan.petersson@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of distribution (time frame: For the first antibiotic administration and if possible for a second administration 48-72 hour later.). The study lists 2 primary outcomes in all. 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 24 Nov 2021.