Pharmacokinetics and Pharmacodynamics of Linezolid Continuous and Intermittent Administration

NCT05801484 | Unknown

• 1 other identifier: 3/2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

continuous infusion; intensive care unit; critically ill; linezolid; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Linezolid plasmatic concentrations

  10 plasmatic concentrations in the first 48h of linezolid treatment, then 1 plasmatic concentration per day until the end of the treatment

  first 2-14 days (during treatment)

Secondary Outcomes (2)

• Linezolid clinical efficacy

  from day 1 to day 30 after therapy initiation

• Linezolid adverse reactions

  from day 1 to day 30 after therapy initiation

Other Outcomes (2)

• Linezolid drug-drug interactions

  from day 1 to day 30 after therapy initiation

• Determination of the minimum inhibitory concentration (MIC) for linezolid for the identified bacteria

  from day 1

Study Arms (2)

Linezolid continuous infusion

EXPERIMENTAL

In the intervention arm, Linezolid is administered 600 mg as loading dose as an infusion lasting one hour (flow rate 300 ml/h), followed by continuous infusion of 1200 mg linezolid over 24 hours (flow rate 25 ml/h) which is immediately initiated. The continuous infusion is administered until the end of the treatment.

Other: Linezolid continuous infusion

Linezolid Intermittent administration

ACTIVE COMPARATOR

In the comparator arm, 600 mg dose of Linezolid is administered as one-hour infusion (flow rate 300 ml/h). Two doses at 12-h intervals are infused until the end of the treatment.

Other: Linezolid continuous infusion

Interventions

Linezolid continuous infusion OTHER

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

Linezolid Intermittent administration; Linezolid continuous infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients hospitalized in the intensive care unit,
• female or male sex,
• age over 18 years,
• linezolid is prescribed by the attending physician, in empirical treatment or based on the antibiogram.

You may not qualify if:

• documented severe liver failure (Child-Pugh C).
• no informed consent signed

Sponsors & Collaborators

• Cluj Municipal Clinical Hospital: lead
• Iuliu Hatieganu University of Medicine and Pharmacy: collaborator

Study Sites (1)

University Clinical Municipal Hospital

Cluj-Napoca, Cluj, 400139, Romania

RECRUITING

Related Publications (1)

• Hui LA, Bodolea C, Vlase L, Hiriscau EI, Popa A. Linezolid Administration to Critically Ill Patients: Intermittent or Continuous Infusion? A Systematic Literature Search and Review. Antibiotics (Basel). 2022 Mar 24;11(4):436. doi: 10.3390/antibiotics11040436.

  PMID: 35453188 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Constantin Bodolea, MD, PhD

  University Of Medicine and Pharmacy Iuliu Hatieganu, Cluj Napoca

  PRINCIPAL INVESTIGATOR

• Ligia A Hui, PharmD

  University Of Medicine and Pharmacy Iuliu Hatieganu, Cluj Napoca

  PRINCIPAL INVESTIGATOR

• Adina Popa, Prof PharmD

  University Of Medicine and Pharmacy Iuliu Hatieganu, Cluj Napoca

  STUDY CHAIR

• Laurian Vlase, Prof, PharmD

  University Of Medicine and Pharmacy Iuliu Hatieganu, Cluj Napoca

  STUDY CHAIR

Central Study Contacts

Constantin Bodolea, MD, PhD

CONTACT

+40726133845; cbodolea@gmail.com

Ligia A Hui, PharmD

CONTACT

+40740385801; ligiahui@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof. Dr.

Model Details: open, prospective, randomized design, with two groups of patients (group with intermittent administration and group with continuous administration of the same daily dose of linezolid).

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: April 6, 2023
• Study Start: July 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: July 30, 2024
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)