Pharmacokinetics and Safety of Antimicrobial Agents Administered by Subcutaneous Route in Patients AGEd Over 65 Years
NCT ID: NCT03583749
Last Updated: 2021-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2019-08-07
2021-09-05
Brief Summary
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Detailed Description
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The investigator's hypothesis is that SC administration of amoxicillin-clavulanate, ceftriaxone and piperacillin-tazobactam has favorable pharmacokinetics and acceptable tolerance compared with IV infusion in elderly patients.
Patients receiving one of the three antibiotics by IV or SC route will be included at steady state (depending on antibiotic treatment) for several blood tests (3 or 4 depending of routes choice) and followed until 15 days after completion of antibiotic treatment in order to evaluate tolerance and efficacy of antibiotic treatment. Physicians in charge of patients will decide antibiotic prescription including administration route. The study will not influence these choices because patients will be included after antibiotic initiation.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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amoxicillin-clavulanate
followed of SC and IV cohort without any randomization because the route will be chosen before inclusion by the physician in charge.
Subcutaneous (SC) route for antibiotic treatment
Patients receiving one of the three antibiotics by SC route without any randomization because the route will be chosen before inclusion by the physician in charge.
Intravenous (IV) route for antibiotic treatment
Patients receiving one of the three antibiotics by IV route without any randomization because the route will be chosen before inclusion by the physician in charge.
ceftriaxone
followed of SC and IV cohort without any randomization because the route will be chosen before inclusion by the physician in charge.
Subcutaneous (SC) route for antibiotic treatment
Patients receiving one of the three antibiotics by SC route without any randomization because the route will be chosen before inclusion by the physician in charge.
Intravenous (IV) route for antibiotic treatment
Patients receiving one of the three antibiotics by IV route without any randomization because the route will be chosen before inclusion by the physician in charge.
piperacillin-tazobactam
followed of SC and IV cohort without any randomization because the route will be chosen before inclusion by the physician in charge.
Subcutaneous (SC) route for antibiotic treatment
Patients receiving one of the three antibiotics by SC route without any randomization because the route will be chosen before inclusion by the physician in charge.
Intravenous (IV) route for antibiotic treatment
Patients receiving one of the three antibiotics by IV route without any randomization because the route will be chosen before inclusion by the physician in charge.
Interventions
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Subcutaneous (SC) route for antibiotic treatment
Patients receiving one of the three antibiotics by SC route without any randomization because the route will be chosen before inclusion by the physician in charge.
Intravenous (IV) route for antibiotic treatment
Patients receiving one of the three antibiotics by IV route without any randomization because the route will be chosen before inclusion by the physician in charge.
Eligibility Criteria
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Inclusion Criteria
* To receive ceftriaxone (1g daily) or amoxicillin-clavulanate (1g/0.2g every 8h) or piperacillin-tazobactam (4g/0.5g every 8h) by SC or IV infusion (30-60minutes) at steady state (48h, 24h and 24h respectively)
* Free, written and informed consent signed by the participant or by a proxy in case of delirium
Exclusion Criteria
* previous inclusion in this study
65 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Claire ROUBAUD-BAUDRON, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital University, Bordeaux
Locations
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CHU de Bordeaux
Bordeaux, , France
Hospital Métropole Savoie
Chambéry, , France
CHU de Grenoble Alpes
Grenoble, , France
Hospices Civils de Lyon
Lyon, , France
University Hospital, Poitiers
Poitiers, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHUBX 2017/37
Identifier Type: -
Identifier Source: org_study_id
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