Clinical trials: Drug Monitoring
Lower Respiratory Tract Infection
Approach for Optimizing Meropenem Therapy in Intubated and Mechanically-Ventilated, Adult Patients With Severe Gram-Negative Lower Respiratory Tract Infection
Antibacterial drugs are facing increasing limitations in terms of effectiveness due to emergence resistance. Improved antibacterial drug monitoring approaches are particularly needed in nosocomial infections occurring in ICU…
- Trial name
- MON4STRAT (NCT03915236)
- Testing
- MON4STRAT Strategy, Control group
- Where
- 3 sites in Belgium, France and 1 more
- Volunteers
- 7 people
- Sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
De Novo Renal Transplant Recipient.
Fixed Dose MMF vs Concentration Controlled MMF After Renal Transplantation
Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure.
- Trial name
- NCT00166244
- Testing
- Mycophenolate Mofetil
- Where
- 67 sites in Australia, Austria and 17 more
- Volunteers
- 901 people
- Sponsor
- Erasmus Medical Center
Opioid Abuse, Prescription Opioid Abuse
Community Pharmacy-Based Prescription Drug Monitoring Program Opioid Risk Assessment Tool
This goal of this observational study is to develop and test the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool. The tool will be an opioid medication risk screener and decision support platform that will be used…
- Trial name
- PharmTool (NCT05706311)
- Testing
- Clinical Decision Support Tool (Moderate Risk), Clinical Decision Support Tool (High Risk), Standard of Care
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of Utah
Prostate Cancer, Neuropathy
a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY
Enzalutamide may lead to various adverse reactions. This study investigates reports of different neurological toxicities in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).
- Conditions
- Prostate Cancer, Neuropathy, Epilepsy, Encephalopathy
- Trial name
- VENDY (NCT04290611)
- Testing
- Enzalutamide
- Where
- France
- Volunteers
- 500,000 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
Rifampin-resistant Tuberculosis, Drug-resistant Tuberculosis
Therapeutic Drug Monitoring for Linezolid in the Treatment of Rifampin-resistant Tuberculosis
This study is a two-arm, pragmatic, open-label, randomized clinical trial to determine the efficacy of Therapeutic Drug Monitoring (TDM) in preventing premature discontinuation of Linezolid (LZD) in participants with…
- Trial name
- THERMOL (NCT06590428)
- Testing
- Therapeutic Drug Monitoring for Linezolid
- Where
- South Africa
- Volunteers
- 280 people
- Sponsor
- Albert Einstein College of Medicine
Intensive Care Unit Patients
Therapeutic Drug Monitoring of Antifungals in Intensive Care Units
Antifungals under- and over-dosing are frequently deplored in patients treated with antifungals and receiving recommended doses, mostly in critically-ill patients.
- Trial name
- Fungi-up (NCT04502771)
- Testing
- Antifungal treatment
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Hospices Civils de Lyon
Respiratory Insufficiency, Overdose of Opiate
ARM-ED: Advanced Respiratory Monitoring Events in Drug Toxicity
There is a drug-related death crisis in Scotland. The majority of these deaths have involved the misuse of opiates (e.g. heroin) and benzodiazepines (e.g. valium) which cause an individual to stop breathing.
- Conditions
- Respiratory Insufficiency, Overdose of Opiate, Sedative Overdose, Sedative Toxicity
- Trial name
- ARM-ED (NCT05358132)
- Testing
- Pneumowave Device placement and data capture
- Where
- United Kingdom
- Volunteers
- 78 people
- Sponsor
- NHS Greater Glasgow and Clyde
Drug Abuse
A First Study in Healthy Volunteers of a New Mobile Phone Application Measuring the Eyes Before and After Medication
This is a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data on the medical device Previct Drugs.
- Trial name
- NCT05731999
- Testing
- Previct Drugs
- Where
- Netherlands
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Kontigo Care AB
Age-Related Macular Degeneration (AMD), Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD
The Efficacy of Home OCT Supported Management in Patients Diagnosed With Neovascular-AMD and Undergoing a Drug Switch to Faricimab
Age-related macular degeneration (AMD) is a common eye disease that can lead to vision loss. The neovascular ("wet") form of AMD is usually treated with repeated injections into the eye.
- Trial name
- NCT07744984
- Testing
- Home Optical Coherence Tomography (Home OCT)
- Where
- Israel
- Volunteers
- 12 people
- Sponsor
- Rabin Medical Center
Kidney Transplant
Home-based Therapeutic Drug Monitoring in Kidney Transplantation
This is a randomized clinical trial to assess an intervention to facilitate patient self-collection of dried blood samples at home for therapeutic drug monitoring of tacrolimus and mycophenolate in kidney transplant recipients.
- Trial name
- NCT05005221
- Testing
- Automated text messages
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- University of Michigan
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
Arthritis, Cancer
Immune CHeckpoint Inhibitors Monitoring of Adverse Drug ReAction
Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events (irAEs) from rhumatologic, endocrinologic, cardiac or other system origin.
- Conditions
- Arthritis, Cancer, Cardiac Disease, Endocrine System Diseases
- Trial name
- CHIMeRA (NCT03492242)
- Testing
- Immune checkpoint inhibitor
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
Psoriasis Vulgaris
Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)
Biologics, such as brodalumab, are currently the most effective treatment option for patients with moderate-to-severe psoriasis.
- Trial name
- BIOLOPTIM-BRO (NCT04080635)
- Testing
- Venapuncture, Patient questionnaires
- Where
- 7 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- University Hospital, Ghent
Psoriasis Vulgaris
Dose Tapering Study of Adalimumab in Psoriasis
The optimal therapeutic serum trough level (Ctrough) of adalimumab was defined between 3,5 and 7,0 µg/ml in patients with plaque type psoriasis. An adalimumab Ctrough above this therapeutic range did not add clinical response.
- Trial name
- NCT04028713
- Testing
- Venapuncture, Dried blood spot, Dose reduction
- Where
- 7 sites in Belgium
- Volunteers
- 19 people
- Sponsor
- University Hospital, Ghent
Intraoperative Ureter Injury
Dose-escalation Study of a Contrast Agent for Delineation of Urological Anatomy in Minimally Invasive Surgery
The purpose of this clinical trial is to study the safety and efficacy of an investigational imaging agent for delineation/visualization of urologic anatomy in the setting of minimally invasive surgery.
- Trial name
- NCT03106038
- Testing
- Nerindocianine for Injection
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Li-Cor, Inc.
Kidney Transplantation
Model-based Medication Dosing Assist for Tacrolimus in Kidney Transplantation
The daily dosing of tacrolimus, the most important immunosuppressant used after kidney transplantation, is a rather complex process in which many factors can have an influence in each individual in a unique way and variable over…
- Trial name
- MIPDTac (NCT07030660)
- Testing
- Model-Informed Precision Dosing (MIPD)
- Where
- Belgium
- Volunteers
- 357 people
- Sponsor
- KU Leuven
Healthy Participants
A Sub Study to Evaluate the Study Medication (Etrasimod) Using Wearable Sensors in Healthy Participants
The purpose of this study is to look at how healthy adults process Etrasimod when assessed by wearable sensors. Etrasimod is taken without food and assessments taken by site staff and then by participants after training.
- Trial name
- NCT06140290
- Testing
- Etrasimod Immediate Release (IR)
- Where
- Belgium
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer
Invasive Fungal Infection
Voriconazole Trough Plasma Levels : Genetic Polymorphism, Efficacy, Safety in Patients With Hematologic Malignancy
Multiple factors are associated with a large variability in voriconazole exposure following standard dose administration, such as non-linear saturable pharmacokinetics, drug-drug interactions, liver disease, patient age, and…
- Trial name
- NCT01148160
- Testing
- voriconazole
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- Asan Medical Center
Infections
Dose Optimization of Rivaroxaban Combined With Rifampicin
The goal of this observational study is to learn about exposure levels of rivaroxaban at different doses in patients with prosthetic joint infection combined with the use of rifampicin.
- Trial name
- NCT05658042
- Where
- China
- Volunteers
- 80 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Multidrug Resistant Gram Negative Bacterial Infections
Multicentric Study About the Usefulness of Monitoring Plasma Levels of Colistin and Sodium Colistimethate in Patients With Infections Due to Multi-drug Resistant Gram Negative Bacilli, Treated With Colistin
Objectives: Main objective: to assess the impact of an intervention for optimizing the dosing of colistin based on its plasma levels in patients with infections due to multi-drug resistant gram negative bacilli.
- Trial name
- NCT01845246
- Testing
- Prospective TDM Arm of colistin
- Where
- 3 sites in Spain
- Volunteers
- 101 people
- Sponsor
- Parc de Salut Mar