About: The effect of therapeutic drug monitoring of beta-lactam and fluoroquinolones on clinical outcome in critically ill patients: the DOLPHIN trial protocol of a multi-centre randomised controlled trial

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About: The effect of therapeutic drug monitoring of beta-lactam and fluoroquinolones on clinical outcome in critically ill patients: the DOLPHIN trial protocol of a multi-centre randomised controlled trial Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	The effect of therapeutic drug monitoring of beta-lactam and fluoroquinolones on clinical outcome in critically ill patients: the DOLPHIN trial protocol of a multi-centre randomised controlled trial
Creator	Muller, A Abdulla, A Endeman, H Ewoldt, T Hunfeld, N Koch, B Polinder, S Rietdijk, W Van Gelder, T
Source	PMC
abstract	BACKGROUND: Critically ill patients undergo extensive physiological alterations that will have impact on antibiotic pharmacokinetics. Up to 60% of intensive care unit (ICU) patients meet the pharmacodynamic targets of beta-lactam antibiotics, with only 30% in fluoroquinolones. Not reaching these targets might increase the chance of therapeutic failure, resulting in increased mortality and morbidity, and antibiotic resistance. The DOLPHIN trial was designed to demonstrate the added value of therapeutic drug monitoring (TDM) of beta-lactam and fluoroquinolones in critically ill patients in the ICU. METHODS: A multi-centre, randomised controlled trial (RCT) was designed to assess the efficacy and cost-effectiveness of model-based TDM of beta-lactam and fluoroquinolones. Four hundred fifty patients will be included within 24 months after start of inclusion. Eligible patients will be randomly allocated to either study group: the intervention group (active TDM) or the control group (non-TDM). In the intervention group dose adjustment of the study antibiotics (cefotaxime, ceftazidime, ceftriaxone, cefuroxime, amoxicillin, amoxicillin with clavulanic acid, flucloxacillin, piperacillin with tazobactam, meropenem, and ciprofloxacin) on day 1, 3, and 5 is performed based upon TDM with a Bayesian model. The primary outcome will be ICU length of stay. Other outcomes amongst all survival, disease severity, safety, quality of life after ICU discharge, and cost effectiveness will be included. DISCUSSION: No trial has investigated the effect of early TDM of beta-lactam and fluoroquinolones on clinical outcome in critically ill patients. The findings from the DOLPHIN trial will possibly lead to new insights in clinical management of critically ill patients receiving antibiotics. In short, to TDM or not to TDM? TRIAL REGISTRATION: EudraCT number: 2017–004677-14. Sponsor protocol name: DOLPHIN. Registered 6 March 2018 . Protocol Version 6, Protocol date: 27 November 2019.
has issue date	2020-01-17(xsd:dateTime)
bibo:doi	10.1186/s12879-020-4781-x
bibo:pmid	31952493
has license	cc-by
sha1sum (hex)	9be287e532ea82107772eae2fc23bde11c57d107
schema:url	https://doi.org/10.1186/s12879-020-4781-x
resource representing a document's title	The effect of therapeutic drug monitoring of beta-lactam and fluoroquinolones on clinical outcome in critically ill patients: the DOLPHIN trial protocol of a multi-centre randomised controlled trial
has PubMed Central identifier	PMC6969462
has PubMed identifier	31952493
schema:publication	BMC Infect Dis
resource representing a document's body	covid:9be287e532ea82107772eae2fc23bde11c57d107#body_text
is schema:about of	named entity 'disease' named entity 'UP TO' named entity 'MODEL' named entity 'AMOXICILLIN WITH CLAVULANIC ACID' named entity 'INCLUDED' named entity 'MEET' named entity 'THERAPEUTIC DRUG MONITORING' named entity 'CEFTRIAXONE' named entity 'LENGTH OF STAY' named entity '60%' named entity 'DOLPHIN' named entity 'ICU' named entity 'DAY 1' named entity 'ANTIBIOTIC' named entity 'INCREASED MORTALITY' named entity 'DOSE ADJUSTMENT' named entity 'CHANCE' named entity 'MORBIDITY' named entity 'START' named entity 'ceftriaxone' named entity 'therapeutic drug monitoring' named entity 'TDM' named entity 'study' named entity 'intensive care unit (ICU)' named entity 'antibiotic' named entity 'ill' named entity 'beta-lactam' named entity 'Bayesian' named entity 'cefotaxime' named entity 'randomly' named entity 'fifty' named entity 'piperacillin' named entity 'ICU' named entity 'therapeutic drug monitoring' named entity 'protocol' named entity 'morbidity' named entity 'therapeutic drug monitoring' named entity 'Critically ill patients' named entity 'ICU' named entity 'TDM' named entity 'beta-lactam' named entity 'TDM' named entity 'ICU' named entity 'antibiotic resistance' named entity 'ceftazidime' named entity 'critically ill patients' named entity 'physiological' named entity 'antibiotics' named entity 'piperacillin' named entity 'randomised controlled trial' named entity 'beta-lactam' named entity 'fluoroquinolones' named entity 'beta-lactam' named entity 'antibiotics' named entity 'univariate analysis' named entity 'acquired resistance' named entity 'fluoroquinolones' named entity 'ventilator' named entity 'EUCAST' named entity 't-test' named entity 'albumin' named entity 'length of stay' named entity 'peer-reviewed' named entity 'serum creatinine' named entity 'critically ill patients' named entity 'evidence based' named entity 'antibiotics' named entity 'clinical outcomes' named entity 't-test' named entity 'extracorporeal' named entity 'mortality rate' named entity 'hospital pharmacist' named entity 'eCRF'

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