Actively Recruiting

Age: 75Years +
All Genders
ID04436991

Antibiotic Dosing in Geriatric Patients at the Emergency Department and Geriatric Ward

Led by University Hospital, Ghent · Updated on 2024-09-19

180

Participants Needed

1

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether current dosing regimens of beta-lactam antibiotics, including Amoxicillin-Clavulanate, Piperacillin-Tazobactam, and Temocillin, reach their pharmacodynamic targets in frail patients aged 75 years or older admitted to a geriatric department. This pilot, monocentric, prospective observational trial addresses a gap since older and frail patients are often excluded from drug studies, and their dosing is usually extrapolated from younger adults without considering differences in how the drugs behave in their bodies. The study involves administering these antibiotics intravenously using standard dosing schedules at Ghent University Hospital. Blood samples are collected through a catheter from the opposite arm of the infusion at early doses (within the first 12 hours) and steady state (after 24 to 48 hours) to measure drug concentrations. Bacteriological samples like blood cultures, urine, and sputum are also collected when possible, and various blood tests, including kidney function and infection markers, are performed. Frailty is assessed using three scoring systems: KATZ, Geriatric 8, and Cumulative Illness Rating Scale. Participants receive standard care antibiotic therapy while researchers monitor drug levels, infection response, and pharmacodynamic target achievement over about one week. Up to five blood samples per dose are collected, with additional samples after therapy if needed. The study measures both total and unbound antibiotic concentrations and evaluates clearance and clinical response. This involves continuous monitoring of vital signs, blood results, and side effects to understand antibiotic behavior in this vulnerable population.

CONDITIONS

Brief Title

Antibiotic Dosing in Geriatric Patients At the Emergency Department

Who Can Participate

Age: 75Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients presenting at the emergency department and later admitted to the geriatric department
  • Age 75 years or older
  • Geriatric profile based on KATZ scale, Geriatric 8 (G8) screening test, or Cumulative Illness Rating Scale (CIRS)
  • Receiving antibiotic treatment with amoxicillin-clavulanate, piperacillin-tazobactam, or temocillin
  • Intravenous access available for blood sampling separate from the antibiotic infusion line
Not Eligible

You will not qualify if you...

  • Admission to units other than the geriatric department, including intensive care units
  • Lack of informed consent
  • Known allergy to beta-lactam antibiotics
  • Prior use of oral amoxicillin-clavulanate before admission for those in the intravenous amoxicillin-clavulanate group

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Approximately 1 week (duration of antibiotic therapy)

Participants who undergo routine care with intravenous antibiotic treatment are observed. Blood samples are taken at early dose within the first 12 hours and at steady state after 24 to 48 hours. Bacteriological specimens such as blood cultures, urine samples, and sputum are collected as part of standard care. Frailty scores are also assessed.

Multiple blood sampling visits during the first 2 days of treatment with additional samples if needed until end of therapy

Trial Site Locations

Total: 1 location

1

University Hospital Ghent

Ghent, Belgium, 9000

Actively Recruiting

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Research Team

P

Peter De Paepe, Prof. Dr.

T

Tania Desmet, Dr.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Risk factors for suboptimal target attainment of commonly used ß-lactam antibiotics in older adults: a prospective cohort study.

Arnaud De Clercq, Tania Desmet, Jerina Boelens...

https://pubmed.ncbi.nlm.nih.gov/41692875