Antibiotic Dosing in Geriatric Patients At the Emergency Department
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age75+
SponsorUniversity Hospital, Ghent
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood sampling
Diagnostic testAt 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 volume to be withdrawn: Maximum 4ml/sample.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 sample
Diagnostic testBacteriological 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.
Hemoculture
Diagnostic testBacteriological 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 sample
Diagnostic testBacteriological 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.
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: Amoxicillin-clavulanate4 interventions
Group B: Piperacillin-tazobactam4 interventions
Group C: Temocillin4 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)2
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.
Time frame
Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)3
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.
Time frame
Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)Secondary outcomes
1
Measured total and unbound concentrations of beta-lactam antibiotics.
To compare measured total and unbound concentrations of beta-lactam antibiotics with predefined pharmacodynamic targets.
Time frame
Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)2
Response to antimicrobial therapy.
To describe therapeutic response to antimicrobial therapy using procalcitonin.
Time frame
The end of individual antibiotic therapy with an average of 1 week3
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.
Time frame
The end of individual antibiotic therapy with an average of 1 week4
Clearance of betalactam antibiotics.
To compare clearance of betalactam antibiotics and correlate with renal function using creatinin clearance en cystatin C.
Time frame
Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)Sponsors and contacts
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Source ClinicalTrials.gov