Population Pharmacokinetics of Anti-infectives in Hospitalized Patients (OptiPOP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02998411|
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : March 25, 2019
In case of sepsis, the therapeutic success is strongly influenced by the choice of anti-infectives (AI) in terms of spectrum, dosage and administration schedule. It is therefore critical to achieve adequate AI concentration as quickly as possible.
This protocol aims to define a common framework to studies conducted jointly by the Antimicrobial Stewardship Team and the Pharmacology department of Cochin hospital for various AI in a range of specific study populations (intensive care unit patients, neutropenic patients…).
These studies will use mathematical modeling methodologies to investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of different AI including PK/PD targets. The effects of covariates on PK and PD parameters will be investigated to better explain the between-subject variability (BSV) and to ultimately suggest individualized dosage regimens.
|Condition or disease||Intervention/treatment|
|Patient Receiving Anti-infectives Whatever Disease||Other: Titration|
Patients with sepsis who receive inadequate AI regimen have a high risk of poor clinical outcomes. It is therefore critical to achieve adequate concentration of the AI as quickly as possible in these patients.
Pharmacokinetics (PK) describes the drug concentration-time courses in body fluids resulting from administration of a certain drug dose, pharmacodynamics (PD) the observed effect resulting from a certain drug concentration. The three PK/PD indices most commonly evaluated for AI are: the ratio of the maximal unbound drug concentration to the MIC (fCmax/MIC), the ratio of the area under the unbound drug concentration-time curve to the MIC (fAUC/MIC) or the percentage of a 24 h time period where the unbound drug concentration exceeds the MIC (fT.MIC). Dosing regimens are chosen to reach a target value of the main PK/PD index.
In hospitalized patients, a high between-subject variability is expected on PK parameters, related to the severity of the disease (sepsis, neutropenia, organ failure...), weight, age (geriatric patients, neonates...) and the co-administration of other medications leading to potential drug interactions. The PD variability is strongly influenced by the immune status, type of infection, inoculum size, comorbidities.
The optiPOP protocol aims to define a common framework to PK/PD studies conducted jointly by the Antimicrobial Stewardship Team and the Pharmacology department of Cochin hospital.
These studies will use mathematical population pharmacokinetic modeling methodologies to investigate PK/PD parameters of various AI in a range of specific study populations (ICU, neutropenic patients…). The effects of covariates on PK and PD parameters will be investigated in order to better explain the between-subject variability and to ultimately suggest individualized dosage regimens.
OptiPOP is a prospective, non-interventional, single center study, based on data regularly collected during the therapeutic drug monitoring of AI.
The antimicrobial stewardship team (AST) has a role in advising clinicians for the diagnostic and treatment of infectious diseases. It is closely involved in daily therapeutic drug monitoring of AI, in collaboration with the department of pharmacology. Patient selection will take place in all medical and surgical wards of the hospital. The AST senior physician will check the eligibility criteria and propose the study to the patient, in accordance with the referring physician. Any adult patient requiring the administration of an AI with at least one plasma concentration measurement conducted in Cochin department of pharmacology will be eligible. The AST physician will give a briefing note to the patient, and the non-oral opposition for the retrieval and analysis of data will be collected.
No intervention or no charge will be made for this study. It is planned to include 60 patients per molecule.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Population Pharmacokinetics Approaches for the Optimization of Anti-infective Concentrations Among Hospitalized Patients|
|Actual Study Start Date :||December 1, 2016|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
|AI treatment and dosage||
- Anti-infectives concentration [ Time Frame: 28 days ]
- Composite measure of the health condition [ Time Frame: 28 days ]Clinical and laboratory data : anthropometric characteristics; organs function, severity score, type of infection, micro-organsim and sensitivity, infectious biological parameters
- Minimum Inhibitory Concentration (MIC) of the suspected or documented pathogen [ Time Frame: 28 days ]Pharmacodynamic characteristics of the molecule
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998411
|Contact: Solen KERNEIS, MD, PhD||01 58 41 19 firstname.lastname@example.org|
|Contact: Elodie HENRY, Master||01 44 49 59 email@example.com|
|Hospital Cochin (AP-HP)||Recruiting|
|Paris, France, 75014|
|Contact: Solen KERNEIS, MD, PhD 01 58 41 19 08 firstname.lastname@example.org|
|Principal Investigator:||Solen KERNEIS, MD, PhD||Assistance Publique - Hôpitaux de Paris|