Patient Receiving Anti-infectives Whatever Disease Clinical Trial
— OptiPOPOfficial title:
Population Pharmacokinetics Approaches for the Optimization of Anti-infective Concentrations Among Hospitalized Patients
NCT number | NCT02998411 |
Other study ID # | NI16012 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 1, 2016 |
Est. completion date | December 2023 |
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 Tea, the Pharmacology department of Cochin hospital and within the APHP Centre hospital group 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 or any other biological compartment. 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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Every adult hospitalized in Cochin hospital, receiving an AI and who require at least one AI concentration measurement or any other biological compartment in the Cochin department of pharmacology Exclusion Criteria: - Patient having notified to the physician the refusal for data recovery |
Country | Name | City | State |
---|---|---|---|
France | Hospital Bichat (AP-HP) | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anti-infectives concentration | 28 days | ||
Secondary | Composite measure of the health condition | Clinical and laboratory data : anthropometric characteristics; organs function, severity score, type of infection, micro-organsim and sensitivity, infectious biological parameters | 28 days | |
Secondary | Minimum Inhibitory Concentration (MIC) of the suspected or documented pathogen | Pharmacodynamic characteristics of the molecule | 28 days |