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Pharmacokinetics and Pharmacodynamics of Linezolid Continuous and Intermittent Administration

NCT05801484 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-04-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the therapeutic efficacy expressed in pharmacokinetic/pharmacodynamic (PK/PD) indices, the clinical response and the risk of adverse reactions following the continuous and intermittent administration of linezolid in critical patients in the Intensive Care Unit.

Subject inclusion criteria:

A minimum of 30 subjects in each group will be included in the study, in accordance with the study inclusion criteria:

* patients hospitalized in the intensive care unit,
* female or male sex,
* age over 18 years,
* linezolid is prescribed by the attending physician, in empirical or targeted treatment

Exclusion criteria:

Patients who have documented severe liver failure (Child-Pugh C score). Patients who refuse to sign the informed consent

Conditions

  • Side-effect of Antibiotic
  • Efficacy
  • Pharmacokinetics
  • Critical Illness
  • Intensive Care Unit ICU

Interventions

OTHER

Linezolid continuous infusion

Continuous infusion of 1200 mg linezolid in 24h, after an initial dose of 600 mg linezolid administered as one hour infusion

Sponsors & Collaborators

  • Iuliu Hatieganu University of Medicine and Pharmacy

    collaborator OTHER

  • Cluj Municipal Clinical Hospital

    lead OTHER

Principal Investigators

  • Constantin Bodolea, MD, PhD · University Of Medicine and Pharmacy Iuliu Hatieganu, Cluj Napoca

  • Ligia A Hui, PharmD · University Of Medicine and Pharmacy Iuliu Hatieganu, Cluj Napoca

  • Adina Popa, Prof PharmD · University Of Medicine and Pharmacy Iuliu Hatieganu, Cluj Napoca

  • Laurian Vlase, Prof, PharmD · University Of Medicine and Pharmacy Iuliu Hatieganu, Cluj Napoca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2024-06-30
Completion
2024-07-30

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05801484 on ClinicalTrials.gov