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

Phase 4

Completed

• Conditions: Pneumonia
• Interventions: Drug: Linezolid

• Registration Number: NCT01805284
• Lead Sponsor: University Ghent

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-27
• Study First Submitted QC: 2013-03-04
• Study First Posted: 2013-03-06
• Primary Completion: 2016-09-30
• Study Completion: 2016-09-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Linezolid	Linezolid	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics/-dynamics of linezolid in blood samples: T>MIC of 100.	Over the course of 72 hours after the first administration of linezolid.	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
Pharmacokinetics/-dynamics of linezolid in urine samples.	During 12 hours after 6th or 7th administration of linezolid.	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.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium