Dosage optimization of piperacillin/tazobactam in ICU patients based on therapeutic drug monitoring of amikacin - OPTIMA

Phase 1

• Conditions: sepsis or septic shock; MedDRA version: 20.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; MedDRA version: 20.0Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2018-003496-36-FR
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-06
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Patient, male or female, over the age of 18, hospitalized in the critical care unit of the Lyon-Sud Hospital Center.
- Patient presenting a clinical picture of sepsis or severe sepsis defined by the latest international recommendations.
- Patient to be treated with amikacin + piperacillin / tazobactam.
- Patient affiliated to a social security scheme,
- having agreed to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Minor patient.
- Patient participating in another research potentially interfering (investigator's judgment) with the results of this study.
- Refusal of the patient to participate in the study.
- Major patient protected under the terms of the law (Public Health Code).
- Patient with a known history of hypersensitivity or contraindication to amikacin, piperacillin or tazobactam.
- Patient known to have previously received piperacillin / tazobactam or amikacin prior to inclusion of the patient.
- Patient treated at the time of inclusion by extra-renal cleansing techniques.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified