NCT02018081

Brief Summary

The aim of this study is 1. to describe levofloxacin pharmacokinetics in ICU patients suffering from pneumonia with taking into account physio-pathological parameters. 2. to verify clinical and bacteriological efficiency and to know if the peak/Minimum Inhibitory Concentration (MIC) ratio \> 5 and Area Under Curve (AUC) /Minimum Inhibitory Concentration(MIC) ratio \> 125. No therapeutic drug monitoring will be performed in this study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 23, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

Enrollment Period

2.5 years

First QC Date

July 4, 2013

Last Update Submit

March 4, 2015

Conditions

Intensive Care Unit SyndromeCommunity-acquired Pneumonia

Keywords

pharmacokinetic study : open, prospective, monocentric

Outcome Measures

Primary Outcomes (1)

  • Levofloxacin dosage regimen, time of administration and time of blood sampling, levofloxacin serum concentrations.

    Levofloxacin concentration assessment at 8 different time points during 12h

Secondary Outcomes (1)

  • Efficiency (clinical,bacteriological, pharmacodynamic)

    12 hours

Study Arms (1)

Levofloxacin

EXPERIMENTAL

Population having a community-acquired pneumonia of which the indication of the treatment is administration of Levofloxacin

Drug: Levofloxacin

Interventions

LevofloxacinDRUG

8 blood sampling by patients between the 48th and 60th

Also known as: pharmacokinetic
Levofloxacin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • severe community-acquired pneumonia due to a strain sensible to levofloxacin
  • Age \> 18 years
  • Informed consent
  • SAPS II (simplified acute physiological score) \> 20 Awaited duration of survival higher than 7 days

You may not qualify if:

  • Historic of allergy to levofloxacin
  • Resistant strain to levofloxacin
  • Pregnancy
  • Contra-indications of levofloxacin use, renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

LevofloxacinPharmacogenomic Variants

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPolymorphism, GeneticGenetic VariationGenetic Phenomena

Study Officials

  • Bernard GEORGES, MD, PhD

    University Hospital of Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 4, 2013

First Posted

December 23, 2013

Study Start

March 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

March 5, 2015

Record last verified: 2015-03

Locations

FR(1)