NCT02998411 Population Pharmacokinetics of Anti-infectives in Hospitalized Patients
| NCT ID | NCT02998411 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Patient Receiving Anti-infectives Whatever Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2016-12-01 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2016-12-01 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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
Contact & Investigator
Etienne CANOUI, MD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT02998411 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Patient Receiving Anti-infectives Whatever Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02998411 currently recruiting?
Yes, NCT02998411 is actively recruiting participants. Contact the research team at etienne.canoui@aphp.fr for enrollment information.
Where is the NCT02998411 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT02998411 clinical trial?
NCT02998411 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Etienne CANOUI, MD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 60 participants.