Population Pharmacokinetics of Anti-infectives in Hospitalized Patients

NCT02998411 | Recruiting

• 1 other identifier: NI16012
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Receiving Anti-infectives Whatever Disease

Keywords

anti-infectives; adults; pharmacokinetic; pharmacodynamic end-points; clinical cure

Outcome Measures

Primary Outcomes (1)

• Anti-infectives concentration

  28 days

Secondary Outcomes (2)

• Composite measure of the health condition

  28 days

• Minimum Inhibitory Concentration (MIC) of the suspected or documented pathogen

  28 days

Study Arms (1)

AI treatment and dosage

Other: Titration

Interventions

Titration OTHER

AI treatment and dosage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 or any other biological compartment.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Cochin Hospital

Paris, Paris, 75014, France

RECRUITING

Study Officials

• Etienne CANOUI, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Etienne CANOUI, MD

CONTACT

01 58 41 42 67; etienne.canoui@aphp.fr

Laure CHOUPEAUX, Master

CONTACT

01 44 38 17 11; laure.choupeaux@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: December 20, 2016
• Study Start: December 1, 2016
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)