Elderly InfectionAGEDNCT04436991
Antibiotic Dosing in Geriatric Patients At the Emergency Department
An observational study of Elderly Infection and Frailty, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
In this pilot study, we will investigate whether - with the current dosing regimens, used in the Ghent University Hospital - pharmacodynamic targets regarding beta-lactam antibiotics (more specific Amoxicilline-Clavulanate, Piperacillin-Tazobactam and Temocillin) are attained in frail patients admitted to the… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Elderly Infection, Frailty, Frail Elderly Syndrome
- What is being tested?
- Blood sampling, Sputum sample and Hemoculture
- How many people
- 180 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Jan 2018to Jan 2025
- How long will I take part?
- 2 Weeks
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Frail elderly patients with a minimum of 75 years old, presenting at the emergency department and in need for hospitalization at the geriatric ward, in which a betalactam antibiotic treatment was started.
Who may be able to join
- Patients presenting at the emergency department and later on admitted to the geriatric department
- Patient age 75 years or older
- Patients with geriatric profile according to KATZ scale, G8 screening test or CIRS score.
- Patient receiving antibiotic treatment (amoxicillin-clavulanate, piperacillin-tazobactam)
- Intravenous access available for blood sampling. For measurement of the peak concentration an intravenous access other than the drug infusion line is required.
Who cannot join
- Admission to other units than the geriatric department incl. the ICU.
- Absence of informed consent
- Known hypersensitivity to beta-lactam antibiotics
- Patients who received oral amoxicillin-clavulanate prior to admission will not be included in the iv. amoxicillin-clavulanate group.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Ghent
Ghent, 9000
Peter De Paepe, Prof. Dr., 003293325211, peter.depaepe@uzgent.be
Tania Desmet, Dr., 003293321559, tania.desmet@uzgent.be
About this study
In this pilot study, we will investigate whether - with the current dosing regimens, used in the Ghent University Hospital - pharmacodynamic targets regarding beta-lactam antibiotics (more specific Amoxicilline-Clavulanate, Piperacillin-Tazobactam and Temocillin) are attained in frail patients admitted to the geriatric department.
Read the detailed description
In drug research studies, older people - and especially patients with a geriatric profile or frailty risk - are very frequently excluded. Moreover, drug dosing is often extrapolated from studies in younger adults with failure to consider potential differences in pharmacokinetics (PK) and pharmacodynamics (PD).
Studies on dosing of beta-lactam antibiotics in geriatric or frail patients aged 75 years or older have, to the best of our knowledge, never been performed.
In this pilot study, we will investigate whether - with the current dosing regimens, used in the Ghent University Hospital - pharmacodynamic targets regarding beta-lactam antibiotics (more specific Amoxicilline-Clavulanate, Piperacillin-Tazobactam and Temocillin) are attained in frail patients admitted to the geriatric department.
This monocentric, prospective, observational trial is currently ongoing at the emergency department and geriatric department of the Ghent University Hospital.
Amoxicillin/clavulanic acid 1000/200mg of piperacillin-tazobactam 4000mg or temocillin 2000mg was infused intravenously over 30 minutes using a syringe pump. The standard dosing regimes were used.
An infusion catheter of minimum 18-gauge was placed in the contralateral arm to the arm in which the antibiotic dose was administered. Blood samples were collected from this catheter at first dose and assumed steady state conditions. Steady state was assumed to be reached after minimal 24h (> 4 doses at four - six hourly interval) of therapy. The goal was to obtain 5 first dose and 5 steady dose samples in every patient.
Material for bacteriological analysis, such as blood cultures, urine samples, sputum, were collected in every patient according to standard care. In case of bacterial growth, MIC's were measured on the reported strains when possible.
Amoxicillin, clavulanic acid, piperacillin, tazobactam and temocillin were measured using a validated ultra-performance liquid chromatographic method with tandem mass spectrometric detection.
Serum creatinine, cystatin C, procalcitonin, infection parameters (CRP, WBC count) and albumin were obtained from standard blood samples performed in these patients at day one and also later on during their therapy.
Three frailty score systems (KATZ, Geriatric 8 - G8, Cumulative Illness Rating Scale - CIRS) were calculated.
- Being tested
- Blood sampling, Sputum sample, Hemoculture, Urine sample
- Keywords
- amoxicillin, piperacillin-tazobactam, temocillin, pharmacokinetics, pharmacodynamics
- Medical subject headings
- Frailty, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingDiagnostic test
At predefined time points through a venous catheter already in place. Max. volume to be withdrawn: Maximum 4ml/sample. Maximum 10 samples/patient.
A last blood sample will be taken, if necessary, after the end of antibiotic therapy, between day 7 and day 14. Though blood results preferably will be used from available data from tests already done during standard treatment.
Samples are collected in lithium-heparin tubes (without gel) and centrifuged immediately (within a maximum of 30 minutes after sampling) at room temperature: 8 minutes at 1885g.
Plasma is then collected and divided in two separated labelled Eppendorf tubes 1.5 ml and immediately frozen at - 80 °C. If this is not immediately possible, tubes are frozen at - 20 °C and at regular time points transferred to a freezer at - 80 °C (minimum twice a day).
Sputum sampleDiagnostic test
Bacteriological specimen, such as blood cultures, urine samples, sputum ea., which are usually collected in every patient according to standard care will be retained. If there is bacterial growth, MIC's will be calculated on these strains for study purpose.
HemocultureDiagnostic test
Bacteriological specimen, such as blood cultures, urine samples, sputum ea., which are usually collected in every patient according to standard care will be retained. If there is bacterial growth, MIC's will be calculated on these strains for study purpose.
Urine sampleDiagnostic test
Bacteriological specimen, such as blood cultures, urine samples, sputum ea., which are usually collected in every patient according to standard care will be retained. If there is bacterial growth, MIC's will be calculated on these strains for study purpose.
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin-clavulanate | Administration of amoxicillin-clavulanate as standard care therapy (4x or 6x 1g/d). Blood sampling in early and steady state dose (up to 5 samplings per dose). Collection of hemocultures, urine samples and sputum samples when possible. Receives: Diagnostic Test: Blood sampling; Diagnostic Test: Sputum sample; Diagnostic Test: Hemoculture; Diagnostic Test: Urine sample | |
| Piperacillin-tazobactam | Administration of piperacillin-tazobactam as standard care therapy (4x 4g/d). Blood sampling in early and steady state dose (up to 5 samplings per dose). Collection of hemocultures, urine samples and sputum samples when possible. Receives: Diagnostic Test: Blood sampling; Diagnostic Test: Sputum sample; Diagnostic Test: Hemoculture; Diagnostic Test: Urine sample | |
| Temocillin | Administration of temocillin as standard care therapy (2x or 3x 2g/d). Blood sampling in early and steady state dose (up to 5 samplings per dose). Collection of hemocultures, urine samples and sputum samples when possible. Receives: Diagnostic Test: Blood sampling; Diagnostic Test: Sputum sample; Diagnostic Test: Hemoculture; Diagnostic Test: Urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood concentrations of amoxicillin-clavulanate.
To investigate whether blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens in first-dose or early-dose conditions and in steady-state conditions.
Measured: Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
Blood concentrations of piperacillin-tazobactam.
To investigate whether blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens in first-dose or early-dose conditions and in steady-state conditions.
Measured: Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
Blood concentrations of temocillin.
To investigate whether blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens in first-dose or early-dose conditions and in steady-state conditions.
Measured: Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
Secondary outcomes (4)
Measured total and unbound concentrations of beta-lactam antibiotics.
To compare measured total and unbound concentrations of beta-lactam antibiotics with predefined pharmacodynamic targets.
Measured: Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
Response to antimicrobial therapy.
To describe therapeutic response to antimicrobial therapy using procalcitonin.
Measured: The end of individual antibiotic therapy with an average of 1 week
Achievement of pharmacodynamic targets measured by questionnaire, vital signs, blood results and side effects.
To compare achievement of pharmacodynamic targets in early-dose and steady-state conditions.
Measured: The end of individual antibiotic therapy with an average of 1 week
Clearance of betalactam antibiotics.
To compare clearance of betalactam antibiotics and correlate with renal function using creatinin clearance en cystatin C.
Measured: Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start3 Jan 2018
- Primary completion3 Sep 2021
- Study completionJan 2025 (estimated)
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 Elderly InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- 180 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tania Desmet, Dr., Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436991
- Sponsor's protocol ID
- EC/2017/1369 (BC-01030)
- Acronym
- AGED
- Status last verified
- Sep 2024
- First submitted
- 9 Jun 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Students participating at the study (registered ethical committee) can consult individual participant data.
Publications
De Clercq A, Desmet T, Boelens J, Somers A, Stove V, Verougstraete N, Brys A, Petrovic M, De Paepe P, De Cock PA. Risk factors for suboptimal target attainment of commonly used ss-lactam antibiotics in older adults: a prospective cohort study. J Antimicrob Chemother. 2026 Feb 2;81(3):dkag048. doi: 10.1093/jac/dkag048.
PubMed 41692875
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Dosing in Geriatric Patients At the Emergency Department
- ClinicalTrials.gov ID
- NCT04436991
- Acronym / sponsor ID
- AGED / EC/2017/1369 (BC-01030)
- Keywords
- amoxicillin, piperacillin-tazobactam, temocillin, pharmacokinetics, pharmacodynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- Jan 2025 (estimated)
- First posted
- 18 Jun 2020 (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.
In this pilot study, we will investigate whether - with the current dosing regimens, used in the Ghent University Hospital - pharmacodynamic targets regarding beta-lactam antibiotics (more specific Amoxicilline-Clavulanate, Piperacillin-Tazobactam and Temocillin) are attained in frail patients admitted to the geriatric department.
Detailed description
In drug research studies, older people - and especially patients with a geriatric profile or frailty risk - are very frequently excluded. Moreover, drug dosing is often extrapolated from studies in younger adults with failure to consider potential differences in pharmacokinetics (PK) and pharmacodynamics (PD).
Studies on dosing of beta-lactam antibiotics in geriatric or frail patients aged 75 years or older have, to the best of our knowledge, never been performed.
In this pilot study, we will investigate whether - with the current dosing regimens, used in the Ghent University Hospital - pharmacodynamic targets regarding beta-lactam antibiotics (more specific Amoxicilline-Clavulanate, Piperacillin-Tazobactam and Temocillin) are attained in frail patients admitted to the geriatric department.
This monocentric, prospective, observational trial is currently ongoing at the emergency department and geriatric department of the Ghent University Hospital.
Amoxicillin/clavulanic acid 1000/200mg of piperacillin-tazobactam 4000mg or temocillin 2000mg was infused intravenously over 30 minutes using a syringe pump. The standard dosing regimes were used.
An infusion catheter of minimum 18-gauge was placed in the contralateral arm to the arm in which the antibiotic dose was administered. Blood samples were collected from this catheter at first dose and assumed steady state conditions. Steady state was assumed to be reached after minimal 24h (> 4 doses at four - six hourly interval) of therapy. The goal was to obtain 5 first dose and 5 steady dose samples in every patient.
Material for bacteriological analysis, such as blood cultures, urine samples, sputum, were collected in every patient according to standard care. In case of bacterial growth, MIC's were measured on the reported strains when possible.
Amoxicillin, clavulanic acid, piperacillin, tazobactam and temocillin were measured using a validated ultra-performance liquid chromatographic method with tandem mass spectrometric detection.
Serum creatinine, cystatin C, procalcitonin, infection parameters (CRP, WBC count) and albumin were obtained from standard blood samples performed in these patients at day one and also later on during their therapy.
Three frailty score systems (KATZ, Geriatric 8 - G8, Cumulative Illness Rating Scale - CIRS) were calculated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin-clavulanate | – | Diagnostic Test: Blood sampling, Diagnostic Test: Sputum sample, Diagnostic Test: Hemoculture, Diagnostic Test: Urine sampleAdministration of amoxicillin-clavulanate as standard care therapy (4x or 6x 1g/d). Blood sampling in early and steady state dose (up to 5 samplings per dose). Collection of hemocultures, urine samples and sputum samples when possible. |
| Piperacillin-tazobactam | – | Diagnostic Test: Blood sampling, Diagnostic Test: Sputum sample, Diagnostic Test: Hemoculture, Diagnostic Test: Urine sampleAdministration of piperacillin-tazobactam as standard care therapy (4x 4g/d). Blood sampling in early and steady state dose (up to 5 samplings per dose). Collection of hemocultures, urine samples and sputum samples when possible. |
| Temocillin | – | Diagnostic Test: Blood sampling, Diagnostic Test: Sputum sample, Diagnostic Test: Hemoculture, Diagnostic Test: Urine sampleAdministration of temocillin as standard care therapy (2x or 3x 2g/d). Blood sampling in early and steady state dose (up to 5 samplings per dose). Collection of hemocultures, urine samples and sputum samples when possible. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Frail elderly patients with a minimum of 75 years old, presenting at the emergency department and in need for hospitalization at the geriatric ward, in which a betalactam antibiotic treatment was started.
Key inclusion criteria (5 listed)
- Patients presenting at the emergency department and later on admitted to the geriatric department
- Patient age 75 years or older
- Patients with geriatric profile according to KATZ scale, G8 screening test or CIRS score.
- Patient receiving antibiotic treatment (amoxicillin-clavulanate, piperacillin-tazobactam)
- Intravenous access available for blood sampling. For measurement of the peak concentration an intravenous access other than the drug infusion line is required.
Key exclusion criteria (4 listed)
- Admission to other units than the geriatric department incl. the ICU.
- Absence of informed consent
- Known hypersensitivity to beta-lactam antibiotics
- Patients who received oral amoxicillin-clavulanate prior to admission will not be included in the iv. amoxicillin-clavulanate group.
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 |
|---|---|---|
| Blood samplingAt predefined time points through a venous catheter already in place. Max. volume to be withdrawn: Maximum 4ml/sample. Maximum 10 samples/patient. A last blood sample will be taken, if necessary, after the end of antibiotic therapy, between day 7 and day 14. Though blood results preferably will be used from available data from tests already done during standard treatment. Samples are collected in lithium-heparin tubes (without gel) and centrifuged immediately (within a maximum of 30 minutes after sampling) at room temperature: 8 minutes at 1885g. Plasma is then collected and divided in two separated labelled Eppendorf tubes 1.5 ml and immediately frozen at - 80 °C. If this is not immediately possible, tubes are frozen at - 20 °C and at regular time points transferred to a freezer at - 80 °C (minimum twice a day). | Diagnostic test | Amoxicillin-clavulanate, Piperacillin-tazobactam, Temocillin |
| Sputum sampleBacteriological specimen, such as blood cultures, urine samples, sputum ea., which are usually collected in every patient according to standard care will be retained. If there is bacterial growth, MIC's will be calculated on these strains for study purpose. | Diagnostic test | Amoxicillin-clavulanate, Piperacillin-tazobactam, Temocillin |
| HemocultureBacteriological specimen, such as blood cultures, urine samples, sputum ea., which are usually collected in every patient according to standard care will be retained. If there is bacterial growth, MIC's will be calculated on these strains for study purpose. | Diagnostic test | Amoxicillin-clavulanate, Piperacillin-tazobactam, Temocillin |
| Urine sampleBacteriological specimen, such as blood cultures, urine samples, sputum ea., which are usually collected in every patient according to standard care will be retained. If there is bacterial growth, MIC's will be calculated on these strains for study purpose. | Diagnostic test | Amoxicillin-clavulanate, Piperacillin-tazobactam, Temocillin |
Primary outcome
Blood concentrations of amoxicillin-clavulanate.
Time frame: Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
To investigate whether blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens in first-dose or early-dose conditions and in steady-state conditions.
Blood concentrations of piperacillin-tazobactam.
Time frame: Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
To investigate whether blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens in first-dose or early-dose conditions and in steady-state conditions.
Blood concentrations of temocillin.
Time frame: Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
To investigate whether blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens in first-dose or early-dose conditions and in steady-state conditions.
4 secondary outcomes
Measured total and unbound concentrations of beta-lactam antibiotics.
Time frame: Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
Response to antimicrobial therapy.
Time frame: The end of individual antibiotic therapy with an average of 1 week
Achievement of pharmacodynamic targets measured by questionnaire, vital signs, blood results and side effects.
Time frame: The end of individual antibiotic therapy with an average of 1 week
Clearance of betalactam antibiotics.
Time frame: Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 41692875De Clercq A, Desmet T, Boelens J, Somers A, Stove V, Verougstraete N, Brys A, Petrovic M, De Paepe P, De Cock PA. Risk factors for suboptimal target attainment of commonly used ss-lactam antibiotics in older adults: a prospective cohort study. J Antimicrob Chemother. 2026 Feb 2;81(3):dkag048. doi: 10.1093/jac/dkag048.
- Individual participant dataSharing planned: Yes. Students participating at the study (registered ethical committee) can consult individual participant data.
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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.
Tania Desmet, Dr. principal investigator
University Hospital, Ghent
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 Elderly Infection and Frailty, run by University Hospital, Ghent at 1 site in Belgium.
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 5 inclusion and 4 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 19 Sep 2024. 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 Belgium. 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 Peter De Paepe, Prof. Dr. (003293325211, peter.depaepe@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood concentrations of amoxicillin-clavulanate. (time frame: Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)). The study lists 3 primary outcomes in all. 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 NCT04436991, 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 19 Sep 2024.