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

NCT03583749 | Unknown

• 1 other identifier: CHUBX 2017/37
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Antimicrobials; Subcutaneous Injection; Antibiotic; Older People

Keywords

Antimicrobial agents; subcutaneous administration; safety; pharmacokinetics; elderly

Outcome Measures

Primary Outcomes (1)

• Plasma antibiotic concentrations

  Describe and compare pharmacokinetics of amoxicillin-clavulanate, ceftriaxone and piperacillin-tazobactam administered by SC and IV routes

  Day 1

Secondary Outcomes (3)

• Number of adverse events

  Day 21

• Number of infection cure

  Day 21

• Number of hospitalisation days

  Day 21

Study Arms (3)

amoxicillin-clavulanate

followed of SC and IV cohort without any randomization because the route will be chosen before inclusion by the physician in charge.

Drug: Subcutaneous (SC) route for antibiotic treatment; Drug: Intravenous (IV) route for antibiotic treatment

ceftriaxone

followed of SC and IV cohort without any randomization because the route will be chosen before inclusion by the physician in charge.

Drug: Subcutaneous (SC) route for antibiotic treatment; Drug: Intravenous (IV) route for antibiotic treatment

piperacillin-tazobactam

followed of SC and IV cohort without any randomization because the route will be chosen before inclusion by the physician in charge.

Drug: Subcutaneous (SC) route for antibiotic treatment; Drug: Intravenous (IV) route for antibiotic treatment

Interventions

Subcutaneous (SC) route for antibiotic treatment DRUG

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.

amoxicillin-clavulanate; ceftriaxone; piperacillin-tazobactam

Intravenous (IV) route for antibiotic treatment DRUG

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.

amoxicillin-clavulanate; ceftriaxone; piperacillin-tazobactam

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be included during their hospitalization. They may be included if they receive first-line antibiotic treatment or other antibiotic therapy, as long as the time to reach pharmacokinetic steady state has been reached. This project involves patients hospitalized in an infectious and tropical or geriatric ward

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (5)

CHU de Bordeaux

Bordeaux, 33000, France

RECRUITING

Hospital Métropole Savoie

Chambéry, 73000, France

RECRUITING

CHU de Grenoble Alpes

Grenoble, 38700, France

RECRUITING

Hospices Civils de Lyon

Lyon, 69000, France

RECRUITING

University Hospital, Poitiers

Poitiers, 86021, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The sampling times chosen are the following: * C0: concentration measured at the end of the therapeutic interval, just before the following infusion, which corresponds to the minimum or residual concentration * Cperf: concentration measured at the end of infusion: immediately after stopping the infusion, which corresponds to the maximum concentration IV * C5h: concentration measured in the elimination phase, 5h after the end of the infusion. For the subcutaneous route only, an additional sample will be taken: * C2h: concentration measured 2h after the end of the SC infusion. The tubes will then be processed in the local pharmacokinetic laboratory as follows: For each antibiotic, the blood samples obtained from each recruitment center will be transported, centrifuged, aliquoted and frozen at the local pharmacology laboratory. The tubes will then be batched to the centralized transport dosing laboratory every 6 months.

MeSH Terms

Interventions

Injections, Subcutaneous

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Claire ROUBAUD-BAUDRON, MD, PhD

  Hospital University, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire ROUBAUD-BAUDRON, MD, PhD

CONTACT

+33 (0) 5 57 82 18 44; claire.roubaud@chu-bordeaux.fr

Aurélie CHERCHOULY

CONTACT

+33 (0) 5 24 54 91 86; aurelie.cherchouly@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 11, 2018
• Study Start: August 7, 2019
• Primary Completion: September 5, 2021
• Study Completion: September 5, 2021
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)