Back to resultsPharmacokinetics of Levofloxacin in Intensive Care Unit (LEVO-PHARM)
Primary Purpose
Intensive Care Unit Syndrome, Community-acquired Pneumonia
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Levofloxacin
Sponsored by
About this trial
This is an interventional treatment trial for Intensive Care Unit Syndrome focused on measuring pharmacokinetic study : open, prospective, monocentric
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Historic of allergy to levofloxacin
- Resistant strain to levofloxacin
- Pregnancy
- Contra-indications of levofloxacin use, renal failure
Sites / Locations
- University Hospital Toulouse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Levofloxacin
Arm Description
Population having a community-acquired pneumonia of which the indication of the treatment is administration of Levofloxacin
Outcomes
Primary Outcome Measures
Levofloxacin dosage regimen, time of administration and time of blood sampling, levofloxacin serum concentrations.
Secondary Outcome Measures
Efficiency (clinical,bacteriological, pharmacodynamic)
age, weight, height, sex, SAPS II, blood urea nitrogen (BUN), creatinine, mechanical ventilation, leukocytes, haemoglobin, procalcitonin, creatinine clearance, proteins, MIC of the strain.
Full Information
NCT ID
NCT02018081
First Posted
July 4, 2013
Last Updated
March 4, 2015
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT02018081
Brief Title
Pharmacokinetics of Levofloxacin in Intensive Care Unit
Acronym
LEVO-PHARM
Official Title
Population Pharmacokinetics of Levofloxacin in Intensive Care Patients With Severe Community-acquired Pneumonia.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intensive Care Unit Syndrome, Community-acquired Pneumonia
Keywords
pharmacokinetic study : open, prospective, monocentric
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levofloxacin
Arm Type
Experimental
Arm Description
Population having a community-acquired pneumonia of which the indication of the treatment is administration of Levofloxacin
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Other Intervention Name(s)
pharmacokinetic
Intervention Description
8 blood sampling by patients between the 48th and 60th
Primary Outcome Measure Information:
Title
Levofloxacin dosage regimen, time of administration and time of blood sampling, levofloxacin serum concentrations.
Time Frame
Levofloxacin concentration assessment at 8 different time points during 12h
Secondary Outcome Measure Information:
Title
Efficiency (clinical,bacteriological, pharmacodynamic)
Description
age, weight, height, sex, SAPS II, blood urea nitrogen (BUN), creatinine, mechanical ventilation, leukocytes, haemoglobin, procalcitonin, creatinine clearance, proteins, MIC of the strain.
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Historic of allergy to levofloxacin
Resistant strain to levofloxacin
Pregnancy
Contra-indications of levofloxacin use, renal failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard GEORGES, MD, PhD
Organizational Affiliation
University Hospital of Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics of Levofloxacin in Intensive Care Unit
We'll reach out to this number within 24 hrs