Primary Objective: - To study the pharmacokinetics (CL, Vd, and F) of ciprofloxacin in cachectic elderly patients and compare with normal weight participants.Secondary Objective(s): - To assess the influence of covariates (such as TBW, LBW, serum…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A farmacokinetic model using Non Linear Mixed Effects Modelling (NONMEM). Model
validation using bootstrap
method or Sampling lmportance Resampling (SlR). The final modelwill be used for
Monte Carlo simulation for multipledosing
regimens and higher dosages.
Secondary outcome
NA
Background summary
Life expectancy is increasing and elderly patients are prone to malnutrition
and underweight, partly as a result of high age itself or as a result of
comorbidities. Dosingguidelines are based on studies in which elderly and
patients with divergent weight are often excluded. Pharmacokinetic studies are
needed to design adequate dosing regimens for special patient populations like
cachectic elderly as cachexia and age are known to be associated with
physiological changes which may influence pharmacokinetics.
There is increasing evidence that frail elderly are subject to adverse health
effects as a result of pneumonia or urinary tract infections. Ciprofloxacin is
an important therapeutic resource for both indications. In addition, outcomes
are known to be improved after timely administration of a right dose of the
right drug. However, for cachectic elderly patients the right ciprofloxacine
dose is currently unknown.
Ciprofloxacin is available as oral or intravenous preparation. However, the
bioavailability in cachectic elderly is unknown.
Therefore it seems prudent to conduct a trial in a cohort of cachectic elderly
patients who are treated with ciprofloxacin in routine clinical care (400mg IV
or 500mg PO).
These subjects will be compared to the pharmacokinetics in a normal-weight
group that was already recruited in the AMIGO trial (2015-004814-84).
This study aims to provide clinical information that will be used to determine
an optimal dosing strategy for obese patients through modeling and simulation.
Study objective
Primary Objective:
- To study the pharmacokinetics (CL, Vd, and F) of ciprofloxacin in cachectic
elderly patients and compare with normal weight participants.
Secondary Objective(s):
- To assess the influence of covariates (such as TBW, LBW, serum creatinine,
Groningen frailty index, MUST score, metabolomics and Glomerular filtration
rate (GFR)) on the pharmacokinetics of ciprofloxacin.
- To develop dosing recommendations for ciprofloxacin in cachectic elderly
patients.
Study design
This is a prospective observational study which will be performed in cachectic
elderly patients being treated with PO ciprofloxacin (n=15) or IV ciprofloxacin
(n=10) in routine clinical care. A control group of 8 healthy volunteers that
was recruited for the AMIGO study will be used(EudraCT: 2015-004814-84).
Study burden and risks
The risk-classification is assessed as negligible to the patient population
receiving ciprofloxacin. Patients will receive ciprofloxacin under routine
clinical care. The main burden associated with the study concists of a single
venapuncture if no venous catheter is available. The samples will be obtained
from this catheter, therefore sample collection itself not of additional
burden.
Van riebeeckweg 212
Hilversum 1213XZ
NL
Van riebeeckweg 212
Hilversum 1213XZ
NL
Listed location countries
Age
Inclusion criteria
- Treated witch ciprofloxacin as a part of routine clinical care
- >75 years of age
- At least one of the following:
o BMI <19
o Unintended weight loss of >10% of total body weight in the previous 12 months
o weight <60kg and BMI<21
o BMI <21 and a positive MUST score for malnutrition
- Participant is able and willing to sign the Informed consent before screening
evaluations.
Exclusion criteria
- Subjects may not be critically ill, i.e. not be admitted to the ICU
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72345.100.20 |