Intensive Care Unit SyndromePhase 4LEVO-PHARMNCT02018081
Pharmacokinetics of Levofloxacin in Intensive Care Unit
A Phase 4 study testing Levofloxacin in people with Intensive Care Unit Syndrome and Community-acquired Pneumonia, run by University Hospital, Toulouse at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Syndrome, Community-acquired Pneumonia
- What is being tested?
- Levofloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Sep 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Historic of allergy to levofloxacin
- Resistant strain to levofloxacin
- Pregnancy
- Contra-indications of levofloxacin use, renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Population Pharmacokinetics of Levofloxacin in Intensive Care Patients With Severe Community-acquired Pneumonia.
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.
- Being tested
- Levofloxacin
- Keywords
- pharmacokinetic study : open, prospective, monocentric
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
Also called pharmacokinetic
8 blood sampling by patients between the 48th and 60th
| Study group | Role | What they receive |
|---|---|---|
| Levofloxacin | Experimental | Population having a community-acquired pneumonia of which the indication of the treatment is administration of Levofloxacin Receives: Drug: Levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levofloxacin dosage regimen, time of administration and time of blood sampling, levofloxacin serum concentrations.
Measured: Levofloxacin concentration assessment at 8 different time points during 12h
Secondary outcomes (1)
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.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startMar 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard GEORGES, MD, PhD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018081
- Sponsor's protocol ID
- 10 150 02
- Acronym
- LEVO-PHARM
- Status last verified
- Mar 2015
- First submitted
- 4 Jul 2013
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics of Levofloxacin in Intensive Care Patients With Severe Community-acquired Pneumonia.
- ClinicalTrials.gov ID
- NCT02018081
- Acronym / sponsor ID
- LEVO-PHARM / 10 150 02
- Keywords
- pharmacokinetic study : open, prospective, monocentric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levofloxacin | Experimental | Drug: LevofloxacinPopulation having a community-acquired pneumonia of which the indication of the treatment is administration of Levofloxacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Historic of allergy to levofloxacin
- Resistant strain to levofloxacin
- Pregnancy
- Contra-indications of levofloxacin use, renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevofloxacinAlso: pharmacokinetic8 blood sampling by patients between the 48th and 60th | Drug | Levofloxacin |
Primary outcome
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
1 secondary outcome
Efficiency (clinical,bacteriological, pharmacodynamic)
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
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Sepsis, Septic Shock
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard GEORGES, MD, PhD principal investigator
University Hospital of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levofloxacin in people with Intensive Care Unit Syndrome and Community-acquired Pneumonia, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.