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Clinical trials for Therapeutic drug monitoring

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    180 result(s) found for: Therapeutic drug monitoring. Displaying page 1 of 9.
    1  2  3  4  5  6  7  8  9  Next»
    EudraCT Number: 2021-003670-31 Sponsor Protocol Number: BC-10433 Start Date*: 2021-09-22
    Sponsor Name:Ghent University Hospital
    Full Title: Impact of Model-Informed Precision Dosing of Vancomycin in Adults: A randomized, controlled clinical trial
    Medical condition: Gram positive infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004538-40 Sponsor Protocol Number: BC-5429 Start Date*: 2020-11-20
    Sponsor Name:Ghent University Hospital
    Full Title: A multicentric randomised controlled clinical trial to study the impact of bedside model-informed precision dosing of vancomycin in critically ill children.
    Medical condition: Gram positive infection
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-007973-19 Sponsor Protocol Number: VORI-ZonMW Start Date*: 2009-04-09
    Sponsor Name:University Medical Center Groningen
    Full Title: Pharmacologic optimization of voriconazole - a prospective clustered group-randomized cross-over trial of therapeutic drug monitoring
    Medical condition: The objective of this prospective stratified cluster randomized cross-over trial is to determine whether pharmacologic optimization of voriconazole by means of therapeutic drug monitoring (TDM) res...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-000650-10 Sponsor Protocol Number: LAS-213 Start Date*: 2020-02-12
    Sponsor Name:Octapharma
    Full Title: An open-label, multicenter, Post-Marketing Requirement study to investigate the safety and tolerability of octaplas™ in the management of pediatric patients who require therapeutic plasma exchange.
    Medical condition: Therapeutic plasma exchange
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-000692-92 Sponsor Protocol Number: MK-8616-089 Start Date*: 2019-02-01
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 4 Double-Blinded, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade ...
    Medical condition: Reversal of neuromuscular blockade (NMB)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10018061 General anesthesia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed) ES (Completed) FI (Completed) BE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2021-003195-13 Sponsor Protocol Number: 02/06/2021/2.0 Start Date*: 2021-06-23
    Sponsor Name:Fakultní nemocnice Ostrava
    Full Title: Importance of therapeutic monitoring of orally administered disease-modifying drugs used in the treatment of multiple sclerosis
    Medical condition: multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004852 10064137 Progression of multiple sclerosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-002962-11 Sponsor Protocol Number: IQUO/01 Start Date*: 2013-05-24
    Sponsor Name:Interessenverband zur Qualitätsicherung der Arbeit niedergelassener Uro-Onkologen in Deutschland (IQUO) e.V.
    Full Title: Optimizing Pazopanib Exposure in RCC Patients through Therapeutic Drug Monitoring Followed by Intrapatient Dose Escalation
    Medical condition: Renal cell carcinoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-000406-11 Sponsor Protocol Number: NL56591.078.16 Start Date*: 2016-04-14
    Sponsor Name:Erasmus University Medical Center
    Full Title: The influence of electroencephalographic Narcotrend Index™ - guidance of propofol administration on recovery from procedural sedation for gastrointestinal endoscopy in children between 1 and 12 years
    Medical condition: There is no specific medical condition under investigation
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-000793-30 Sponsor Protocol Number: PedTac Start Date*: 2013-10-22
    Sponsor Name:Oslo University Hospital - Rikshospitalet
    Full Title: The PedTac study Development of a pediatric pharmacokinetic population model for Tacrolimus
    Medical condition: Solid organ transplantation
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004870 10052779 Transplant rejections HLT
    16.0 100000004848 10043411 Therapeutic drug monitoring analyses HLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NO (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-000789-19 Sponsor Protocol Number: MiniCept Start Date*: 2007-05-30
    Sponsor Name:CHU de Liège, Domaine Universitaire du Sart Tilman
    Full Title: Withdrawal of Calcineurin Inhibitors (CNIs) during administration of Mycophenolate Mofetil (MMF) in liver transplant patients suffering adverse effects from CNIs: Study of the reduction in rejectio...
    Medical condition: liver transplant patients suffering adverse effects from treatment with calcineurin inhibitors
    Disease: Version SOC Term Classification Code Term Level
    9.1 10050434 Prophylaxis against liver transplant rejection LLT
    9.1 10054980 Immunosuppressant drug therapy LLT
    9.1 10052538 Adverse drug reaction NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-002388-33 Sponsor Protocol Number: ZKSJ0086 Start Date*: 2016-09-05
    Sponsor Name:Friedrich-Schiller-University Jena
    Full Title: Therapeutic drug monitoring (TDM) for personalized antibiotic treatment with piperacillin-tazobactam (PipTaz) in patients with febrile neutropenia after myelo-suppressive cytostatic chemotherapy
    Medical condition: Patients with febrile neutropenia after myelo-suppressive chemotherapy treated with piperacillin/tazobactam
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002122-23 Sponsor Protocol Number: NL44307.078.13 Start Date*: 2013-07-11
    Sponsor Name:Erasmus University Medical Center
    Full Title: The influence of electroencephalographic Narcotrend Index™- guidance of of propofol administration on recovery from procedural sedation for gastrointestinal endoscopy in paediatric patients
    Medical condition: There is no medical condition which is under investigation. Paediatric patients, scheduled for gastrointestinal endoscopy under procedural sedation are eligible for inclusion. Depth of sedation wil...
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003220-32 Sponsor Protocol Number: EpicStudy Start Date*: 2022-01-18
    Sponsor Name:IRCCS MATERNO INFANTILE BURLO GAROFOLO
    Full Title: Impact of early proactive therapeutic drug monitoring on the durability and efficacy of infliximab therapy in pediatric inflammatory bowel disease: a multicenter open-label randomized-control trial.
    Medical condition: Pediatric Inflammatory Bowel Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10021184 IBD LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-005124-24 Sponsor Protocol Number: 6378707817 Start Date*: 2018-01-31
    Sponsor Name:Erasmus MC Cancer Institute
    Full Title: Therapeutic Drug Monitoring guided tamoxifen dosing: a feasibility study in patients with hormone positive breast cancer
    Medical condition: Hormone positive breast cancer
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-004676-22 Sponsor Protocol Number: M16-066 Start Date*: 2019-01-14
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10009900 Colitis ulcerative PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) SK (Trial now transitioned) AT (Trial now transitioned) ES (Ongoing) SE (Trial now transitioned) NL (Trial now transitioned) DK (Completed) GR (Trial now transitioned) PL (Trial now transitioned) DE (Trial now transitioned) LT (Trial now transitioned) PT (Trial now transitioned) GB (GB - no longer in EU/EEA) LV (Trial now transitioned) SI (Trial now transitioned) BG (Trial now transitioned) HR (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-002562-23 Sponsor Protocol Number: 2015-768 Start Date*: 2017-06-27
    Sponsor Name:Hvidore Hospital
    Full Title: Therapeutic drug monitoring and continuous infusion of beta-lactam antibiotics in patients with bacteraemia.
    Medical condition: Bacteraemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000019999 10003998 Bacteraemia, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002883-20 Sponsor Protocol Number: WALIBI-001 Start Date*: 2013-09-30
    Sponsor Name:University Medical Center Groningen
    Full Title: Walking the Isobole of drug Interaction: Comparison of hemodynamic effects, cerebral and tissue oxygenation for 4 equipotent combinations of propofol and remifentanil
    Medical condition: elective ophthalmic surgery under general anesthesia.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-003586-94 Sponsor Protocol Number: DONEPEZIL001 Start Date*: 2018-01-08
    Sponsor Name:Fakultní nemocnice Hradec Králové
    Full Title: Monitoring of changes in donepezil concentrations, biomarkers of oxidative stress and activity of acetylchonesterase in the cerebrospinal fluid and plasma of patients with Alzheimer disease.
    Medical condition: Alzheimer's disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10001897 Alzheimer's disease (incl subtypes) HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-000010-38 Sponsor Protocol Number: PAEDMED_v1.0 Start Date*: 2018-03-20
    Sponsor Name:Department of Clinical Pharmacology/Medical University of Vienna
    Full Title: Development of intravascular microdialysis as a tool for therapeutic drug monitoring in children.
    Medical condition: cohort A: We will administer a single dose of vancomycin, cefuroxime or gentamicin to healthy volunteers. The administration of the antibiotics in cohort A is for study purposes only. cohort B: We...
    Disease:
    Population Age: Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-004804-38 Sponsor Protocol Number: 073-202 Start Date*: 2011-12-13
    Sponsor Name:ViroDefense Inc
    Full Title: A Randomized, Blinded, Placebo-Controlled, Poliovirus Challenge Study To Evaluate The Therapeutic Efficacy, Safety, Tolerability And Pharmacokinetics Of Orally Administered V-073 In Healthy Adult V...
    Medical condition: Poliomyelitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10036017 Poliomyelitis viral infections HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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