Clinical trials: Therapeutic Drug Monitoring (TDM)
Depression - Major Depressive Disorder, Depressive Episodes
TDM-Guided Treatment With SSRIs in Hospitalized Adults and Children
Depression in childhood and adolescence is a serious and increasing public-health problem associated with profound short- and long-term consequences, including impaired social and educational functioning, increased risk of…
- Trial name
- NCT07478796
- Testing
- Fluoxetine, Escitalopram, Sertralin
- Where
- Poland
- Volunteers
- 180 people
- Sponsor
- Poznan University of Medical Sciences
Graft Versus Host Disease, Acute, Hematopoietic Stem Cell Transplantation
Infliximab Efficacy, TDM and Serum TNFα Levels in Pediatric HSCT Recipients With aGVHD: Prospective Observational Study
In children receiving a hematopoietic stem cell transplant (HSCT), blood levels of TNFalpha (an inflammatory cytokine) at the onset of the acute GVHD (graft-versus-host disease) could be correlated with the severity of the…
- Trial name
- NCT05362630
- Where
- Italy
- Volunteers
- 28 people
- Sponsor
- University of Pisa
Respiratory Diseases, Neurological Disorders
Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and Adolescents
This study is to investigate breath analysis (breath metabolomics) combined with established bioinformatic tools as a platform for companion diagnostics.
- Conditions
- Respiratory Diseases, Neurological Disorders, Type 1 Diabetes
- Trial name
- EBECA (NCT04461821)
- Testing
- Real-time SESI-MS breath analysis, Off-line breath analysis, Blood analysis
- Where
- Switzerland
- Volunteers
- 3,600 people
- Sponsor
- University Children's Hospital Basel
Adverse Drug Reaction (ADR)
The INTEGRATE Study: Integrated Pharmacogenetics, TDM and Active Pharmacovigilance as Innovative Tools for the Optimisation and Appropriateness of Drug Therapy
The primary goal of this observational study is to evaluate the feasibility of implementing a multidisciplinary approach based on pharmacogenetics, TDM (Therapeutic Drug Monitoring) and MedReview into the clinical practice in…
- Trial name
- INTEGRATE (NCT06822959)
- Testing
- Pharmacogenetics, TDM and MedReview
- Where
- 2 sites in Italy
- Volunteers
- 450 people
- Sponsor
- Direzione centrale salute, politiche sociali e disabilità
Blood Sample for Routine Care, Term or Premature Newborns (28 to 44 Amenorrhea Weeks)
TDM of Gentamicin and Vancomycin, in Neonates, Using Dried Blood Spot Sampling.
Gentamicin and vancomycin, widely used in neonatology, are antibiotics with a narrow therapeutic index and a risk of nephrotoxicity and ototoxicity.
- Conditions
- Blood Sample for Routine Care, Term or Premature Newborns (28 to 44 Amenorrhea Weeks), Gentamicin and/or Vancomycin
- Trial name
- MIDOMEN (NCT03651115)
- Testing
- therapeutic drug monitoring
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Caen
Apnea of Prematurity
MICropsampling for CAffeine in PREMature Newborns
Caffeine is one of the top five most prescribed drugs in neonatology. Caffeine has many beneficial impacts on preterm infants (cardiac, neurologic and pulmonary). One of these beneficial impacts is to prevent apnea.
- Trial name
- MICCAPREM (NCT07779915)
- Testing
- collection of an extra drop of capillary blood
- Where
- 2 sites in France
- Volunteers
- 40 people
- Sponsor
- University Hospital, Limoges
Treatment Failure of Second-line ART in Asian HIV-infected Children
Second-line Therapy
This study will help identify which ARV candidates should be prioritized for pediatric use in resource-limited settings
- Trial name
- TASER-P (NCT01788891)
- Where
- 8 sites in Indonesia, Malaysia and 2 more
- Volunteers
- 300 people
- Sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
Acute Myeloid Leukemia (AML)
Venetoclax TDM in Newly Diagnosed AML: Exposure-Response and Prognosis
Venetoclax combined with azacitidine (VEN-AZA) is the current first-line standard of care for newly diagnosed acute myeloid leukemia (AML) patients unfit for intensive chemotherapy.
- Trial name
- ND-AML (NCT07670130)
- Where
- China
- Volunteers
- 50 people
- Sponsor
- The First Affiliated Hospital of Soochow University
Autism Spectrum Disorder
Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT
The aim of this study is to test whether therapeutic drug monitoring of risperidone in children with autism spectrum disorder and comorbid behavioral problems is able to reduce metabolic side effect burden, while retaining…
- Trial name
- SPACe2:STAR (NCT05146245)
- Testing
- Therapeutic Drug Monitoring, Risperidone plasma level
- Where
- Netherlands
- Volunteers
- 140 people
- Sponsor
- Erasmus Medical Center
Non-valvular Atrial Fibrillation (NVAF), Venous Thromboembolism (VTE)
Precision Antithrombotic Therapy
The goal of this observational study is to systematically analyze the relationship between trough/peak concentrations of novel oral anticoagulants (NOACs) and antiplatelet drugs with clinical events, aiming to provide high-level…
- Conditions
- Non-valvular Atrial Fibrillation (NVAF), Venous Thromboembolism (VTE), MI(Myocardial Infarction), Ischemic Stroke
- Trial name
- NCT07654634
- Testing
- Not applicable- observational study
- Where
- China
- Volunteers
- 5,000 people
- Sponsor
- The Third Xiangya Hospital of Central South University
Acute Lymphoblastic Leukemia
TDM of Asparaginase in ALL2008
Asparaginase is a cornerstone in the treatment of ALL. In most contemporary protocols like in NOPHO ALL2008 prolonged asparaginase treatment has been implemented.
- Trial name
- NCT04843514
- Where
- 2 sites in Denmark
- Volunteers
- 765 people, healthy volunteers welcome
- Sponsor
- Aarhus University Hospital
Hematologic Neoplasms, Gram-Negative Bacterial Infections
Ceftazidime-Avibactam PK/PD and Resistance in Hematology Patients
This is a prospective, single-arm, observational, exploratory clinical study to evaluate whether the standard fixed dose of ceftazidime-avibactam (CAZ-AVI) achieves sufficient drug exposure (pharmacokinetic/pharmacodynamic, or…
- Conditions
- Hematologic Neoplasms, Gram-Negative Bacterial Infections, Pseudomonas Aeruginosa Infection, Klebsiella Pneumoniae Infections
- Trial name
- CZA-TDM (NCT07703644)
- Testing
- Ceftazidime-avibactam, Therapeutic Drug Monitoring (TDM) and Microbiological Surveillance
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Sizhou Feng
Depression, Anorexia Nervosa
Therapeutic Drug Monitoring in Child and Adolescent Psychiatry
The investigators aim to analyse in adolescents with mental illness effectiveness, side effects, and serum level concentrations of antipsychotics (olanzapine and aripiprazole), antidepressants (Duloxetine, Atomoxetine) by means…
- Conditions
- Depression, Anorexia Nervosa, ADHD
- Trial name
- TDMKJP (NCT01057329)
- Testing
- Atomoxetine, Duloxetine, Olanzapine
- Where
- Austria
- Volunteers
- 200 people
- Sponsor
- Medical University of Vienna
Mycoses, Neutropenia
Therapeutic Drug Monitoring (TDM) of Voriconazole and Correlation With CYP2C19 Genotype in Korean Populations
Voriconazole (VCZ), the antifungal drug active against Candida and Aspergillus is a substrate of CYP2C19, whose proportion of poor metabolizers is about ~20% in Asian population.
- Conditions
- Mycoses, Neutropenia, Bone Marrow Transplantation
- Trial name
- NCT00673348
- Where
- 2 sites in South Korea
- Volunteers
- 40 people
- Sponsor
- The Catholic University of Korea
Pediatric Continuous Renal Replacement Therapy, Dialysis
Safety and TDM of Continuous Infusion Vancomycin Through Continuous Renal Replacement Therapy Solution
The purpose of this investigation is to evaluate the safety of delivering continuous infusion (CI) vancomycin in pediatric CRRT by utilizing CI via by mixing the vancomycin into the CRRT solution(s).
- Conditions
- Pediatric Continuous Renal Replacement Therapy, Dialysis, Renal Failure
- Trial name
- NCT02663596
- Testing
- Vancomycin
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Drexel University
Sepsis, Hemodynamic Instability
Therapeutic Drug Monitoring in Patients With Difficult-to-Treat Gram-Negative Bacterial Infections
A prospective, open-label, randomized controlled trial will be conducted to evaluate a novel TDM-guided therapy in management of DT-GNB infections.
- Conditions
- Sepsis, Hemodynamic Instability, Bacterial Infections, Therapeutic Drug Monitoring
- Trial name
- TDM-RCT (NCT05942157)
- Testing
- Therapeutic Drug Monitoring (TDM)
- Where
- Singapore
- Volunteers
- 810 people
- Sponsor
- Singapore General Hospital
Depression, Affective Disorders, Psychotic
Routine Plasma Level Determination to Compare Actual vs Expected Plasma Levels at Psychiatric Inpatient Admission
Compliance with treatment is notoriously low in psychiatric patients. Traditional methods of monitoring compliance, however, may underreport nonadherence to treatment.
- Trial name
- NCT00627510
- Testing
- Routine psychiatric inpatient treatment
- Where
- Austria
- Volunteers
- 161 people
- Sponsor
- Medical University Innsbruck
Linezolid, Tuberculosis Multi Drug Resistant Active
Linezolid Tolerance During the BPaL Regimen With Dosage Personalization Based on Therapeutic Drug Monitoring (TDM) During Multidrug-Resistant Tuberculosis Treatment
Multidrug-resistant tuberculosis (MDR-TB) poses a significant challenge to global public health. Globally, the World Health Organization (WHO) estimates the number at 400,000 patients with MDR-TB for 2023.
- Conditions
- Linezolid, Tuberculosis Multi Drug Resistant Active, Therapeutic Drug Monitoring (TDM)
- Trial name
- PLOT-TB (NCT07477119)
- Testing
- Linezolid dose personalization based on TDM
- Where
- Guinea
- Volunteers
- 150 people
- Sponsor
- Marco Schiuma
Therapeutic Drug Monitoring (TDM), Tuberculosis
Collect Data From Patients Receiving Standardized Anti-tuberculosis Therapy, Collect Monitoring Data, and Evaluate Treatment Efficacy and Potential Adverse Reactions.
The purpose of this clinical trial is to investigate the correlation between anti-tuberculosis drug concentration monitoring and treatment efficacy and safety through analytical studies.The main questions it aims to answer…
- Trial name
- Tuberculosis (NCT07607288)
- Testing
- Antituberculosis drugs Group
- Where
- China
- Volunteers
- 2,215 people
- Sponsor
- Beijing Chest Hospital
Febrile Neutropenia
Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance
This clinical trial focuses on children with cancer who face infections after receiving chemotherapy. Chemotherapy affects the bone marrow, leading to a decrease in the production of certain white blood cells, particularly those…
- Trial name
- DAR-ARC (NCT06293677)
- Testing
- Dosage Adjustment Rules for Augmented Renal Clearance (DAR-ARC) for piperacillin-tazobactam and meropenem, Standard dosages of piperacillin-tazobactam or meropenem
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- Centre Hospitalier Universitaire Vaudois