Population pharmacokinetics of levofloxacin in intensive care patients with severe community-acquired pneumonia - Lévo-Pharm

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002177-34-FR

Enrollment

Registered

2011-09-06

Start date

2013-11-07

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

community-acquired pneumonia MedDRA version: 14.0 Level: LLT Classification code 10032502 Term: Other specified alveolar and parietoalveolar pneumopathies System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: TAVANIC 5 mg/ml, solution pour perfusion Product Name: Tavanic Product Code: NA Pharmaceutical Form: Solution for injection/infusion

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Historia of allergy to levofloxacin Resistant strain to levofloxacin Pregnancy Contra-indications of levofloxacin use, renal failure

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this study is to describe levofloxacin pharmacokinetics in ICU patients suffering from pneumonia with taking into account physio-pathological parameters;Secondary Objective: to verify clinical and bacteriological efficiency and to know if the peak/MIC ratio > 5 and AUC/MIC ratio > 125;Primary end point(s):	—

Countries

France

Contacts

Public ContactDirection de la Recherche Clinique

CHU de Toulouse

pasturaud.a@chu-toulouse.fr+330561 77 83 47+33

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026