Patient Receiving Anti-infectives Whatever DiseaseOptiPOPNCT02998411
Population Pharmacokinetics of Anti-infectives in Hospitalized Patients
An observational study of Patient Receiving Anti-infectives Whatever Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Receiving Anti-infectives Whatever Disease
- What is being tested?
- Titration
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2016to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients hospitalized in Cochin hospital receiving an AI agent and who require at least one AI concentration measurement or any other biological compartment.
Who may be able to join
- 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
Who cannot join
- Patient having notified to the physician the refusal for data recovery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Cochin Hospital
Paris, Paris, 75014
Etienne CANOUI, MD, 01 58 41 42 67, etienne.canoui@aphp.fr
About this study
Official title: Population Pharmacokinetics Approaches for the Optimization of Anti-infective Concentrations Among Hospitalized Patients
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.
Read the 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, the Pharmacology department of Cochin hospital and within the APHP Centre hospital group.
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 and within the APHP Centre hospital group. 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 or any other biological compartment conducted in Cochin department of pharmacology and within the APHP Centre hospital group 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.
- Being tested
- Titration
- Keywords
- anti-infectives, adults, pharmacokinetic, pharmacodynamic end-points, clinical cure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TitrationOther
| Study group | Role | What they receive |
|---|---|---|
| AI treatment and dosage | Not described Receives: Other: Titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-infectives concentration
Measured: 28 days
Secondary outcomes (2)
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
Measured: 28 days
Minimum Inhibitory Concentration (MIC) of the suspected or documented pathogen
Pharmacodynamic characteristics of the molecule
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start1 Dec 2016
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Receiving Anti-infectives Whatever DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Etienne CANOUI, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998411
- Sponsor's protocol ID
- NI16012
- Acronym
- OptiPOP
- Status last verified
- Oct 2025
- First submitted
- 16 Nov 2016
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics Approaches for the Optimization of Anti-infective Concentrations Among Hospitalized Patients
- ClinicalTrials.gov ID
- NCT02998411
- Acronym / sponsor ID
- OptiPOP / NI16012
- Keywords
- anti-infectives, adults, pharmacokinetic, pharmacodynamic end-points, clinical cure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, the Pharmacology department of Cochin hospital and within the APHP Centre hospital group.
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 and within the APHP Centre hospital group. 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 or any other biological compartment conducted in Cochin department of pharmacology and within the APHP Centre hospital group 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AI treatment and dosage | – | Other: Titration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients hospitalized in Cochin hospital receiving an AI agent and who require at least one AI concentration measurement or any other biological compartment.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patient having notified to the physician the refusal for data recovery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Titration | Other | AI treatment and dosage |
Primary outcome
Anti-infectives concentration
Time frame: 28 days
2 secondary outcomes
Composite measure of the health condition
Time frame: 28 days
Minimum Inhibitory Concentration (MIC) of the suspected or documented pathogen
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Etienne CANOUI, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Receiving Anti-infectives Whatever Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Etienne CANOUI, MD (01 58 41 42 67 ext. +33, etienne.canoui@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-infectives concentration (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.