Clinical trials: Model Informed Precision Dosing
Gram-Positive Bacterial Infections
Model-informed Precision Dosing for Linezolid
Study Rationale: Previous in vitro and retrospective in vivo studies suggest that optimal linezolid concentrations (between 2 and 7 mg/L) achieve clinical efficacy and microbiological eradication while minimizing side effects…
- Trial name
- LINEMAP (NCT06444802)
- Testing
- Linezolid
- Volunteers
- 28 people
- Sponsor
- University of Hamburg-Eppendorf
Amoxicillin-clavulanate, Piperacillin-tazobactam
Precision Dosing of Beta-lactam Antibiotics in Critically Ill Children
The overall objective of this study is to investigate the impact of early model-informed precision dosing (MIPD) on target attainment of three beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam and…
- Conditions
- Amoxicillin-clavulanate, Piperacillin-tazobactam, Meropenem
- Trial name
- MOMENTUM (NCT06929702)
- Testing
- Beta-lactam antibiotic, Beta-lactam model-informed precision dosing
- Where
- Belgium
- Volunteers
- 58 people
- Sponsor
- University Hospital, Ghent
Aspergillosis Invasive, Fungal Infection
Individualized First Maintenance Doses of Voriconazole Through a Multiparametric Algorithm
The goal of this interventional single-arm study is to evaluate the interest of a multiparametric algorithm for individualization of first voriconazole maintenance doses for improvement of initial voriconazole exposure in adult…
- Conditions
- Aspergillosis Invasive, Fungal Infection, Hematologic Malignancy
- Trial name
- VORIPRECI (NCT06582186)
- Testing
- Individualization of first voriconazole maintenance doses
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Grenoble
Inflammatory Bowel Diseases, Crohn Disease
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
The goal of this clinical trial is to investigate if dosage of Ustekinumab (UST) and Vedolizumab (VDZ) based on Model-Informed Precision Dosing (MIPD) is equally as efficient in keeping adults with Inflammatory Bowel Disease…
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- Trial name
- MOVE-IT (NCT06788340)
- Testing
- PK-model to decide when to dose Vedolizumab and Ustekinumab
- Where
- 6 sites in Denmark
- Volunteers
- 166 people
- Sponsor
- Odense University Hospital
Pharmacokinetics, Area Under Curve
Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment
This is a prospective observational study of MIPD in clinical practice for paediatric kidney transplant patients using tacrolimus and mycophenolic acid in Radboudumc.
- Conditions
- Pharmacokinetics, Area Under Curve, Tacrolimus, Immunosuppressive Agents
- Trial name
- MISSION (NCT06095895)
- Testing
- venipuncture
- Where
- Netherlands
- Volunteers
- 29 people
- Sponsor
- Radboud University Medical Center
Vancomycin
Precision Dosing of Vancomycin in Critically Ill Children
The overall objective of this project is to investigate the large-scale utility of MIPD of vancomycin at point-of-care in ICU children.
- Trial name
- BENEFICIAL (NCT04666948)
- Testing
- vancomycin model-informed precision dosing, Vancomycin
- Where
- 7 sites in Belgium
- Volunteers
- 314 people
- Sponsor
- University Hospital, Ghent
Tuberculosis, Pulmonary
DoseTB-individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis
The goal of this observational study is to investigate whether model-informed precision dosing (MIPD), as a clinical support for early individualised dosing in addition to the national TB care program, can optimise the drug…
- Trial name
- DoseTB (NCT06585358)
- Testing
- MIPD
- Where
- 2 sites in Sweden
- Volunteers
- 30 people
- Sponsor
- Karolinska Institutet
Patent Ductus Arteriosus, Preterm
Precision Dosing of Oral Ibuprofen for PDA, A Pilot RCT
Newborns born early are at risk for a serious health problem called patent ductus arteriosus (PDA). PDA is a passageway between heart and lung that can cause life-threatening complications such as bleeding in the brain or even…
- Trial name
- MIPD-PDA (NCT07143201)
- Testing
- Standard Dose - Ibuprofen oral suspension, Precision Dose - Ibuprofen oral suspension
- Where
- Canada
- Volunteers
- 26 people
- Sponsor
- Hamilton Health Sciences Corporation
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
Vancomycin
Model-informed Precision Dosing of Vancomycin in Adults
The overall objective of this project is to investigate the utility of model-informed precision dosing (MIPD) of vancomycin in non-critically ill adults.
- Trial name
- NCT05535075
- Testing
- Vancomycin model-informed precision dosing, Vancomycin
- Where
- 2 sites in Belgium
- Volunteers
- 155 people
- Sponsor
- University Hospital, Ghent
Bacterial Infections
Pharmacokinetics of Teicoplanin in Intensive Care and Haematology Patients
Characterize teicoplanin PK in critically ill patients with a specific focus on alterations of exposure due to variability in renal function.
- Trial name
- PLATO (NCT04096092)
- Testing
- No intervention
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- Radboud University Medical Center
Hematological Malignancies, Critical Illness
Using a Population Pharmacokinetic Model to Estimate the Dosage of Teicoplanin in Patients With Hematologic Malignancy or Critical Illness
Model Informed Precision Dosing (MIPD) integrates clinical data to optimize dosing for patients with unstable pharmacokinetics, like those with hematologic malignancies or critical illnesses.
- Trial name
- NCT06674330
- Testing
- concentration of teicoplanin
- Volunteers
- 600 people
- Sponsor
- National Taiwan University Hospital
Bone Marrow Transplantation, AML
Model-Informed Precision Dosing on Cyclosporine Therapy in Hematopoietic Stem Cell Transplant Recipients
The purpose of this study is to develop a new tool that helps doctors choose the right cyclosporine dose for patients undergoing bone marrow transplantation.
- Trial name
- NCT07695571
- Volunteers
- 300 people
- Sponsor
- Yasmin medhat munir Mohamed
Pediatric Kidney Transplantation
Model-Informed Precision Dosing of Tacrolimus in Pediatric Kidney Transplantation
The purpose of this study is to develop a novel and applicable dosing algorithm that helps support the clinical decision to achieve tacrolimus levels within the optimal immunosuppression range despite sparse sampling in routine…
- Trial name
- NCT07549230
- Volunteers
- 130 people
- Sponsor
- Helwan University
Postoperative Pain, Postoperative Analgesia
A Predictive Model for Postoperative Analgesic Requirements After Abdominal Surgery
Postoperative pain remains a common challenge after abdominal surgery despite the use of standard multimodal pain management strategies.
- Conditions
- Postoperative Pain, Postoperative Analgesia, Opioid Analgesic Requirement, Pain Management After Abdominal Surgery
- Trial name
- NCT07803575
- Testing
- Intravenous Morphine Patient-Controlled Analgesia
- Where
- Malaysia
- Volunteers
- 65 people
- Sponsor
- Chaw Sook Hui
Model Informed Precision Dosing
Model-Informed Precision Dosing on Amikacin and Vancomycin Therapy in Critically Ill Children
Achieving optimal antibiotic exposure in critically ill pediatric patients is difficult due to (their) dynamic physiology and variability.
- Trial name
- NCT07315438
- Testing
- MIPD Tool
- Where
- Turkey (Türkiye)
- Volunteers
- 41 people
- Sponsor
- Hacettepe University