Clinical trial NCT02897648: Evaluation of Pharmacokinetic / Pharmacodynamic and Tolerance Assessment of Dermal Administration of Beta-lactams in the Elderly
Official title: Evaluation of Pharmacokinetic / Pharmacodynamic and Tolerance Assessment of Dermal Administration of Beta-lactams in the Elderly
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Beta-Lactams
Aged Subject
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 2
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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%).

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

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of change of residual concentration of Beta-Lactam antibiotic
timeFrame: Minute 30, hour 24, Day 7. Then once a Week 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Secondary outcomes:
measure: Assessment of patient healing (infection free)
timeFrame: Day 14 and day 90
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: EL HELALI Najoua, MD
role: PRINCIPAL_INVESTIGATOR
References: