Pharmacokinetics and Safety of Antimicrobial Agents Administered by Subcutaneous Route in Patients AGEd Over 65 Years

Last updated: February 11, 2021
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Recruiting

Phase

N/A

Condition

Drugs

Treatment

N/A

Clinical Study ID

NCT03583749
CHUBX 2017/37
  • Ages > 65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged over 65
  • To receive ceftriaxone (1g daily) or amoxicillin-clavulanate (1g/0.2g every 8h) orpiperacillin-tazobactam (4g/0.5g every 8h) by SC or IV infusion (30-60minutes) atsteady state (48h, 24h and 24h respectively)
  • Free, written and informed consent signed by the participant or by a proxy in case ofdelirium

Exclusion

Exclusion Criteria:

  • criteria for legislation (justice protection, subject participating to anotherresearch including a period of exclusion)
  • previous inclusion in this study

Study Design

Total Participants: 150
Study Start date:
August 07, 2019
Estimated Completion Date:
September 05, 2021

Study Description

Antibiotic administration through subcutaneous (SC) injection is common practice in France, especially in Geriatrics as an alternative to intravenous (IV) route in case of poor venous access or delirium (Forestier et al. CMI 2015). Whereas tolerance of such a practice seems to be reasonable (Roubaud-Baudron et al. Age and Ageing 2017), sparse PK/PD data are available. Most PK/PD studies include young and healthy subjects, yet elderly patients often have multimorbidity , poly medication, renal insufficiency and cachexia which may disturb antibiotics PK/PD. Compared to intravenous (IV) route, SC route is less painful and less frequently associated with infectious or thrombotic complication. A recent study carried out in Bordeaux University Hospital comparing PK/PD data on ertapenem SC or IV administrations in patients aged over 75 showed that area under the curve (AUC) and probability to maintain free ertapenem concentration above the Minimum inhibitory concentration (MIC) during at least 40% of time (fT>MIC>40%) were not significantly different (manuscript in progress).

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.

Connect with a study center

  • CHU de Bordeaux

    Bordeaux, 33000
    France

    Active - Recruiting

  • Hospital Métropole Savoie

    Chambéry, 73000
    France

    Active - Recruiting

  • CHU de Grenoble Alpes

    Grenoble, 38700
    France

    Active - Recruiting

  • Hospices Civils de Lyon

    Lyon, 69000
    France

    Active - Recruiting

  • University Hospital, Poitiers

    Poitiers, 86021
    France

    Active - Recruiting

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