Antibiotic Dosing in Geriatric Patients At the Emergency Department
AGED
1 other identifier
observational
180
1 country
1
Brief 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 geriatric department.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 3, 2018
CompletedFirst Submitted
Initial submission to the registry
June 9, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedSeptember 19, 2024
September 1, 2024
3.7 years
June 9, 2020
September 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
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.
Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
Response to antimicrobial therapy.
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.
The end of individual antibiotic therapy with an average of 1 week
Clearance of betalactam antibiotics.
Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
Study Arms (3)
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.
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.
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.
Interventions
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).
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.
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.
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Ghent
Ghent, 9000, Belgium
Biospecimen
Whole blood, serum, plasma, blood cultures, urine samples, sputum.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tania Desmet, Dr.
University Hospital, Ghent
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2020
First Posted
June 18, 2020
Study Start
January 3, 2018
Primary Completion
September 3, 2021
Study Completion
January 1, 2025
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- During the whole study course.
- Access Criteria
- To be approved by ethical committee.
Students participating at the study (registered ethical committee) can consult individual participant data.