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

NCT02897648 | Terminated DMC

• 1 other identifier: BETALACUTANE
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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:

• 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of patient healing (infection free)

  Day 14 and day 90

Interventions

Assessment of dermal administration of Beta-Lactams DRUG

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

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Patient Refusal expressed or legal guardian
• polymicrobial infection

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

• EL HELALI Najoua, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 13, 2016
• Study Start: June 26, 2015
• Primary Completion: August 30, 2022
• Study Completion: March 6, 2023
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

FR (1)