Pharmacokinetic and Pharmacodynamic Evaluation of Linezolid Administered Intravenously in MRSA-positive, Morbidly Obese Patients With Pneumonia

NCT01805284 | Completed Phase 4

• 2 other identifiers: 2012/7882012-005127-33
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of the study are: (i) to evaluate the proportion of patients who attain a T\>MIC (Minimum Inhibitory Concentration) of 100% and the time frame in which they do so. The investigators therefore plan to measure unbound linezolid trough concentrations before administration of the second, third, fourth and fifth dose. Furthermore, the investigators will assess the AUC0 - 24h/MIC in all study subjects. Therefore, multiple plasma samples will be drawn after the fourth or fifth dose, when steady state conditions are reached. (ii) to describe the pharmacokinetic variability of unbound linezolid concentrations in this cohort using a population pharmacokinetic model and to assess the expected probability of target attainment (PTA) by MIC against MRSA. Twenty adult, MRSA-positive, morbidly obese patients with clinically and radiologically documented pneumonia are to be included. Therefore, a multi-centre, international observational study is necessary. Given the specific target population this study is not feasible in a single-centre approach. The goal is to find up to 6 centres that anticipate including 3 to 4 patients in the study within a time frame of one year. Included patients should receive at least 6 doses of linezolid. Linezolid must be administered intravenously (iv) over a one hour controlled infusion (with use of a volumetric infusion pump).

Conditions

Pneumonia

Keywords

pneumonia

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics/-dynamics of linezolid in blood samples: T>MIC of 100.

  A total of 17 blood samples will be collected over 72 hours after the first administration of linezolid, using a catheter. There will be evaluation of the proportion of patients who attain a T\>MIC (Minimum Inhibitory Concentration) of 100% and the time frame in which they do so. The investigators therefore plan to measure unbound linezolid trough concentrations before administration of the second, third, fourth and fifth dose. Furthermore, the investigators will assess the AUC0 - 24h/MIC in all study subjects. Therefore, multiple plasma samples will be drawn after the fourth or fifth dose, when steady state conditions are reached

  Over the course of 72 hours after the first administration of linezolid.

• Pharmacokinetics/-dynamics of linezolid in urine samples.

  This collection will be done using a catheter that was already in place, or will be collected in containers if no catheter is present at the time of this collection.

  During 12 hours after 6th or 7th administration of linezolid.

Study Arms (1)

Linezolid

EXPERIMENTAL

Drug: Linezolid

Interventions

Linezolid DRUG

600 mg linezolid as a 1 hour controlled infusion (acceptable time frame is between 30 and 120 minutes), twice, at least 3 days.

Linezolid

Eligibility Criteria

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

You may not qualify if:

• Contraindications as described in the summary of product characteristics (SPC).

Sponsors & Collaborators

• University Ghent: lead
• University Hospital, Ghent: collaborator
• Pfizer: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Linezolid

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dirk Vogelaers, Ph.D., M.D.

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2013
• First Posted: March 6, 2013
• Study Start: February 1, 2013
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

BE (1)