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AN EXPLORATORY PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF CEPHALOSPORIN AND FLUOROQUINOLONE IN ICU PATIENTS


- candidate number23463
- NTR NumberNTR5632
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-dec-2015
- Secondary IDsMEC-2015-502 MEC Erasmus MC
- Public TitleAN EXPLORATORY PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF CEPHALOSPORIN AND FLUOROQUINOLONE IN ICU PATIENTS
- Scientific TitleAN EXPLORATORY PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF CEPHALOSPORIN AND FLUOROQUINOLONE IN ICU PATIENTS
- ACRONYMEXPAT study
- hypothesis
- Healt Condition(s) or Problem(s) studiedIntensive 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 receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jan-2016
- planned closingdate1-jan-2017
- Target number of participants200
- InterventionsThere is no intervention in this study that may affect patient treatment.
- Primary outcometo 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 outcomeComparison of observed PK/PD indices of the individual antibiotics with the length of ICU stay and sickness severity scores in ICU patients.
- TimepointsAt day 2 after start of the therapy 5 bloodsamples will be taken
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc A Abdulla
- CONTACT for SCIENTIFIC QUERIESDr. B.C.P. Koch
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD7-dec-2015 - 27-feb-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl