Older People Clinical Trial
— PhASAgeOfficial title:
Pharmacokinetics and Safety of Antimicrobial Agents Administered by Subcutaneous Route in Patients AGEd Over 65 Years
Elderly people are more prone to develop infection with a poorer prognosis compared to young people. Physicians may encounter difficulties regarding antimicrobial agents administration route. In fact, poor venous access and behavioral disturbance are frequent issues. The subcutaneous (SC) route may be a safe alternative, but sparse data are available in the literature. The present study aims to describe Pharmacokinetics (PK) / Pharmacodynamics (PD) characteristics of antibiotics (amoxicillin/clavulanate, ceftriaxone and piperacillin/tazobactam) subcutaneous administration in patients aged over 65.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | September 5, 2021 |
Est. primary completion date | September 5, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - Aged over 65 - 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: - criteria for legislation (justice protection, subject participating to another research including a period of exclusion) - previous inclusion in this study |
Country | Name | City | State |
---|---|---|---|
France | 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 |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma antibiotic concentrations | Describe and compare pharmacokinetics of amoxicillin-clavulanate, ceftriaxone and piperacillin-tazobactam administered by SC and IV routes | Day 1 | |
Secondary | Number of adverse events | Occurrence of adverse events (AEs) up to 15 days after the end of local antibiotherapy (edema, pain, erythema, necrosis) and systemic (AEs described in the Summary of Product Characteristics for antibiotics) | Day 21 | |
Secondary | Number of infection cure | rate of infection cure at the end of antibiotic treatment up to 15 days after the end of antibiotic therapy | Day 21 | |
Secondary | Number of hospitalisation days | Describe the times of hospitalisation | Day 21 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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