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

NCT02897648 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2023-03-08

No results posted yet for this study

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%).

Conditions

  • Beta-Lactams
  • Aged Subject

Interventions

DRUG

Assessment of dermal administration of Beta-Lactams

Evaluation of Pharmacokinetic / Pharmacodynamic of dermal administration of Beta-Lactams

Sponsors & Collaborators

  • Fondation Hôpital Saint-Joseph

    lead OTHER

Principal Investigators

  • EL HELALI Najoua, MD · Fondation Hôpital Saint-Joseph

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-26
Primary Completion
2022-08-30
Completion
2023-03-06

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02897648 on ClinicalTrials.gov