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

Aged Subject Clinical Trial

— BETALACUTANE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02897648
• Other study ID #: BETALACUTANE
• Status: Terminated
• Start date: June 26, 2015
• Est. completion date: March 6, 2023

Study information

• Verified date: March 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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%).

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 6, 2023
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aged Subject
• Beta-Lactams

Intervention

Drug:
• Assessment of dermal administration of Beta-Lactams
Evaluation of Pharmacokinetic / Pharmacodynamic of dermal administration of Beta-Lactams

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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