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CompletedNCT00255996Updated Jul 14, 2009

Evaluation Of Linezolid Pk Profile In Burns Patients

A Phase 1 interventional study of linezolid in Burns, sponsored by Pfizer. Completed at 3 sites in France. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-14.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Evaluation of linezolid pk profile in burns patients

02

Conditions studied

  • Burns

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03

In context

Burns

719 studies on the registry are indexed under Burns; 145 are open to participants now.

This study's enrollment of 16 is below the median of 40 across 524 interventional studies indexed under Burns.

Browse Burns studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subject with a Body Mass Index (BMI) \< 30 kg/m\². For patient with major thermal injuries, the weight will be collected before the burn ;
  • Patients with major thermal injuries >40% body area including 3rd degree burns with full thickness burns ;
  • Patients hospitalized for at least 10 days since their thermal injury occurred ;

Exclusion criteria

Exclusion Criteria:

  • Contra-indications to use linezolid as mentioned in the SmPC (Summarized Product Characteristics) : hypersensitivity to linezolid use or to any of its components, non-controlled hypertension, phaeochromocytoma, carcinoid syndrome, hyperthyroidism, bipolar disorders, schizoaffective disorders, acute confused state of mind, pregnancy, and breastfeeding ;
  • Drugs metabolised by monoamine oxydase (MAO) should be evaluated for potential drug-to-drug interaction;
  • Subject treated by: selective serotonin reuptake inhibitors (Prozac\®, Effexor\®, Ixel\® \…), tricyclic antidepressant (Anafranil\®, Sinequan\®, Surmontil\®, Tofranil\®), 5HT1 receptor agonists (triptan) direct or indirect sympathomimetic (including adrenergic bronchodilator, pseudoephedrine and phenylpropylamine), vasopressor (adrenaline and noradrenaline), dopaminergic drugs (dopamine, dobutamine), phenetidine or buspirone should be evaluated for potential drug-to-drug interaction;
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Interventions

  • Druglinezolid
06

What researchers measure

Primary outcomes

  1. To assess and compare pharmacokinetic parameters of a single dose 1-hour intravenous linezolid (Zyvox) at 600 mg in patients with major thermal injuries (>40% body area) and in healthy volunteers

Secondary outcomes

  1. To assess and compare tolerability and safety of a single dose of 600mg IV linezolid administered in patients with major thermal injuries (>40% body area) and in healthy volunteers.

07

Study locations

3 sites
  • Pfizer Investigational Site
    Nantes, 44093, France
  • Pfizer Investigational Site
    Paris, 75015, France
  • Pfizer Investigational Site
    Paris, 75679, France
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00255996
Lead sponsor
Pfizer
First posted
Nov 21, 2005
Start date
May 2006
Completion
Jan 2007
Last update
Jul 14, 2009

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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