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Trial record 33 of 26590 for:    Anti-Infective Agents

Population Pharmacokinetics of Anti-infectives in Hospitalized Patients (OptiPOP)

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ClinicalTrials.gov Identifier: NCT02998411
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
AI treatment and dosage Other: Titration



Primary Outcome Measures :
  1. Anti-infectives concentration [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. 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

  2. Minimum Inhibitory Concentration (MIC) of the suspected or documented pathogen [ Time Frame: 28 days ]
    Pharmacodynamic characteristics of the molecule



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults patients hospitalized in Cochin hospital receiving an AI agent and who require at least one AI concentration measurement.
Criteria

Inclusion Criteria:

  • Every adult hospitalized in Cochin hospital, receiving an AI and who require at least one AI concentration measurement in the Cochin department of pharmacology

Exclusion Criteria:

  • Patient having notified to the physician the refusal for data recovery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998411


Contacts
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Contact: Solen KERNEIS, MD, PhD 01 58 41 19 08 solen.kerneis@aphp.fr
Contact: Elodie HENRY, Master 01 44 49 59 53 elodie.henry@aphp.fr

Locations
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France
Hospital Cochin (AP-HP) Recruiting
Paris, France, 75014
Contact: Solen KERNEIS, MD, PhD    01 58 41 19 08    solen.kerneis@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Solen KERNEIS, MD, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02998411     History of Changes
Other Study ID Numbers: NI16012
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
anti-infectives
adults
pharmacokinetic
pharmacodynamic end-points
clinical cure

Additional relevant MeSH terms:
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Anti-Infective Agents