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

NCT ID: NCT01805284

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-09-30

Brief Summary

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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

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Conditions

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Pneumonia

Keywords

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pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Linezolid

Group Type EXPERIMENTAL

Linezolid

Intervention Type DRUG

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

Interventions

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Linezolid

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

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

Contraindications as described in the summary of product characteristics (SPC).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dirk Vogelaers, Ph.D., M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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Ghent University Hospital

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2012-005127-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2012/788

Identifier Type: -

Identifier Source: org_study_id