Evaluation of Pharmacokinetic / Pharmacodynamic and Tolerance Assessment of Dermal Administration of Beta-lactams in the Elderly (BETALACUTANE)

The route of subcutaneous administration of drugs has become a common practice in some specialties (palliative care, geriatrics).

This is an alternative to oral, sublingual, rectal or intravenous Many drugs are used by subcutaneous route but few clinical studies evaluating the level of scientific relevance justifies their use.

The purpose of this study is to assess:

1. / Determine that there is no difference between the subcutaneously compared to intravenous administration in terms of dosage and serum PK / PD of Beta lactam objectives in a geriatric population.
2. / The safety and lack of toxicity of administrations subcutaneously.

Advantages disadvantages

• easy Of establishment
• Simplicity Monitoring and manipulation
• Reduced Risk of infection
• No Risk of venous thrombosis
• Lower cost Simple -Technique for support at home taking
• Limitation Aggressive gestures
• multiplicity Of all possible injection sites
• Technique Of choice for agitated patients or confused -Risk of localized edema (<1000mL / 24 / site)
• Use Impossible for some drugs
• Risk Discomfort and intolerance at the injection site

A practical study was conducted among 382 physicians (289 geriatricians and 93 infectious disease specialists). Among them 97.5% reported regular use of the subcutaneous route for the administration of antibiotics.

Declarative criteria pretend curb the use of this route was the lack of data Pk / Pd (61.2%); the absence of marketing authorization for the subcutaneous route (34.5%); the absence of serum assay available (2.1%).

Study Overview

• Status: Recruiting
• Conditions: Beta-Lactams; Aged Subject
• Intervention / Treatment: Drug: Assessment of dermal administration of Beta-Lactams

Detailed Description

PROTOCOL

Primary objective :

• Determine that there is no difference between the subcutaneously compared to intravenous administration in terms of dosage and serum PK / PD objectives Beta lactam in a geriatric population.

Secondary objectives:

• Clinical evaluation at J14 and J90 (healing, death)
• Clinical tolerance of subcutaneously by self-assessment or hetero-evaluation of the existence of cognitive disorders

Monitoring of antibiotic dosages:

• Making systematic assay serum concentrations of residual antibiotics in the range of 30 min prior to reinjection H24 after starting treatment and then weekly monitoring.
• Realization of the assays according to the method of Liquid Chromatography-Mass Spectrometry (LC-MS)

Patient monitoring of J1-J14:

• Clinical monitoring and biological usual

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: EL HELALI Najoua, MD; Email: nelhalali@hpsj.fr
• Study Contact Backup: Name: Bernard DURAND GASSELIN, MD; Phone Number: +33 1 44 12 70 33; Email: bdurandgasselin@hpsj.fr

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 75014
      • Recruiting
      • Groupe Hospitalier Paris Saint Joseph
      • Contact: BEAUSSIER Helene, PhD, PharmD; Phone Number: +33 1 44 12 70 38; Email: hbeaussier@hpsj.fr
      • Contact: Mohamed CHERIFI, PharmD; Phone Number: +33 1 44 12 70 84; Email: mcherifi@hpsj.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged of >74 years old with Gram-negative bacilli and gram-positive cocci susceptible to beta-lactam

Description

Inclusion Criteria:

• Geriatric Population (≥ 75 years)
• Infection may cause bacteremia or not: Gram-negative bacilli and gram-positive cocci susceptible to beta-lactam

Exclusion Criteria:

• Patient Refusal expressed or legal guardian
• polymicrobial infection

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of change of residual concentration of Beta-Lactam antibiotic	• Making systematic assay serum concentrations of residual antibiotics in the range of 30 min prior to reinjection H24 after starting treatment and then weekly monitoring.an	Minute 30, hour 24, Day 7. Then once a Week 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of patient healing (infection free)	Evaluation of healing to day 14 and day 90. The answer should be: Yes / No	Day 14 and day 90

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Investigators: Principal Investigator: EL HELALI Najoua, MD, Groupe Hospitalier Paris Saint Joseph

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: September 1, 2016
• First Submitted That Met QC Criteria: September 7, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Lactams; beta-Lactams
• Other Study ID Numbers: BETALACUTANE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED