The aim of this study is to describe the utility of beta-lactam and fluoroquinolone TDM programs in tertiary ICUs. Therefore, the main objective is to document whether empirical antibiotic dosing regimens of these antibiotics achieve defined…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Achievement of the PK/PD targets: time that free (unbound) fraction of
beta-lactam concentration remains above the MIC during a dosing interval
(100%*T>MIC and 100%*T>4xMIC) and for the fluoroquinolone the Area Under the
concentration-time Curve for the free (unbound) fraction of above the MIC
(fAUC/MIC) ratio, maximum serum concentration (fCmax) and the fCmax/MIC ratio.
Secondary outcome
Comparison of observed PK/PD indices of the individual antibiotics with the
length of ICU stay and sickness severity scores in ICU patients.
Background summary
Emerging evidence supports the importance of optimized antibiotics exposure in
intensive care unit (ICU) patients, while evidence based antibiotic dosing in
ICU patients in clinical practice is limited. Changes in pharmacokinetic (PK)
parameters of antibiotics in subpopulations of critically ill patient have been
defined in previous studies. However, there are no data from studies assessing
whether the issues identified in a controlled research environment correspond
to clinical practice. Assessment is essential in order to determine whether
actions, such as the use of therapeutic drug monitoring (TDM), are required to
change our existing antibiotic prescribing practices in ICU patients. The
potential benefits of a TDM-based approach include a better outcome because of
more appropriate antibiotic concentrations, but also less resistance
development and avoidance of toxicity. It is most commonly used when the PK and
therefore the optimal dose of a drug for an individual patient are difficult to
predict. In clinical practice, this approach has been routinely used for many
years for vancomycin and aminoglycosides. However, expansion of this practice
to beta-lactam and fluoroquinolone antibiotics, which are frequently used to
treat infections in critically ill patients, has not been widely tested as a
routine intervention. This is very unfortunate, because the contemporary
antibiotic dosing is debatable in severely ill patients as most dosing
references have been derived from studies that do not consider the occurrence
of pathophysiological changes in critical illness.
Study objective
The aim of this study is to describe the utility of beta-lactam and
fluoroquinolone TDM programs in tertiary ICUs. Therefore, the main objective is
to document whether empirical antibiotic dosing regimens of these antibiotics
achieve defined therapeutic target concentrations, 2 days after start of the
therapy in ICU patients.
Study design
The design is a multicenter, prospective, observational pharmacokinetic and
pharmacodynamic study.
Study burden and risks
Blood sampling can hurt and give a bruise. Altogether we take off 25 ml extra
blood. This volume presents no problems in adults.
's Gravendijkwal 230
Rotterdam 3000 CA
NL
's Gravendijkwal 230
Rotterdam 3000 CA
NL
Listed location countries
Age
Inclusion criteria
All the patients admitted to the ICU or internal medicine ward and given standard of care intravenous therapy of either one or both of the target antibiotic classes are included. Antibiotic initiation based on clinical suspicion of infection and/or cultured pathogens susceptible to the target drugs, initial dosage prescription, and duration of therapy are at the discretion of the attending physician. ;In order to be eligible to participate in this study, a subject must also meet all of the following criteria:
* Written informed consent has been obtained from the patient or their legally authorized representative.
* Receiving intravenous antibiotic therapy of the target drugs.
* Suitable intravenous/intra-arterial access to facilitate sample collection.
* Treatment should be aimed for at least at 3 days.
* Bacterial isolates sample are obtainable before start of the target drugs.
Exclusion criteria
* Consent not obtained.
* <18 years of age.
* Antibiotic cessation within 72h after start of the therapie.
* Medium care and burn wound patients 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 | NL53551.078.15 |