|- candidate number||23463|
|- NTR Number||NTR5632|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-dec-2015|
|- Secondary IDs||MEC-2015-502 MEC Erasmus MC|
|- Public Title||AN EXPLORATORY PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF CEPHALOSPORIN AND FLUOROQUINOLONE IN ICU PATIENTS|
|- Scientific Title||AN EXPLORATORY PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF CEPHALOSPORIN AND FLUOROQUINOLONE IN ICU PATIENTS|
|- ACRONYM||EXPAT study|
|- Healt Condition(s) or Problem(s) studied||Intensive care, Antibiotics, Pharmacodynamics, Pharmacokinetics|
|- Inclusion 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 of identification of expected sampling.
- Medium care and burn wound patients admitted to the ICU.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-jan-2016|
|- planned closingdate||1-jan-2017|
|- Target number of participants||200|
|- Interventions||There is no intervention in this study that may affect patient treatment.|
|- Primary outcome||to document whether empirical antibiotic dosing regimens of these antibiotics achieve defined therapeutic target concentrations in ICU patients.: Achievement of the PK/PD targets. PK/PD indices are calculated for each individual patient.|
|- 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.|
|- Timepoints||At day 2 after start of the therapy 5 bloodsamples will be taken|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc A Abdulla|
|- CONTACT for SCIENTIFIC QUERIES||Dr. B.C.P. Koch|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||7-dec-2015 - 27-feb-2016|