PK Analysis of Moxifloxacin in the Treatment of CAP

Completed

• Conditions: Pneumonia

• Registration Number: NCT01983839
• Lead Sponsor: University of Aarhus

Brief Summary

At the Department of Infectious Diseases, Aarhus Denmark, moxifloxacin is used in the empirical treatment of severe community-acquired pneumonia (CAP). This study was designed to determine the pharmacokinetics of moxifloxacin 400 mg/day to patients treated empirically for CAP. To accomplish this aim, we established a pharmacokinetic population model. This approach was adopted with the dual purpose of assessing the potential efficacy of the drug and performing Monte-Carlo simulations to characterize the maximal MICs for which recommended pharmacokinetic-pharmacodynamic (PK-PD) targets are obtained for pathogens commonly known to cause CAP.

Detailed Description

We determined the pharmacokinetic profile of moxifloxacin 400 mg/day in 18 patients treated empirically for community-acquired pneumonia. . Moxifloxacin plasma concentrations were determined the day after therapy initiation using ultra high performance liquid chromatography. The moxifloxacin plasma concentration-time profiles were described with a one compartment model, using NONMEM. Peak drug concentrations (Cmax) and 24-hour area under the free drug concentration-time curve values (fAUC0-24) predicted for each patient were evaluated against epidemiological cut-off MIC values for Streptococcus pneumoniae, Haemophilus influenzae and Legionella pneumophilia. PK-PD targets adopted were Cmax/MIC ≥ 12.2 for all pathogens, fAUC0-24/MIC \> 34 for S. pneumoniae and fAUC0-24/MIC \> 75 for H. influenzae and L. pneumophilia. The same PK-PD estimates were used in the simulations of probability of target attainment (PTA) versus MIC.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-14
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2015-02-10
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-25
• Last Update Submitted: 2015-03-25
• Results First Posted: 2015-04-06
• Last Update Posted: 2015-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Patients with community-acquired pneumonia, treated with moxifloxacin

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Exclusion Criteria

• Under 18 years of age

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Peak Plasma Concentration (Cmax)	The second day of Moxifloxacin treatment	The moxifloxacin plasma concentration-time profiles were described with a one compartment model with first-order absorption and elimination rate. The model estimated median values of total Cmax for the current study population were reported.; Each individual model predicted Cmax were divided by the ECOFF MIC for S. pneumoniae (0.5 mg/L), H. influenzae (0.125 mg/L) and L. pneumophilia (1.0 mg/L)
Area Under the Free Concentration-time Curve (fAUC0-24)	The second day of Moxifloxacin treatment	The moxifloxacin plasma concentration-time profiles were described with a one compartment model with first-order absorption and elimination rate. The model estimated median values of fAUC0-24 for the current study population were reported.; fAUC0-24 were divided by the ECOFF MIC for S. pneumoniae (0.5 mg/L), H. influenzae (0.125 mg/L) and L. pneumophilia (1.0 mg/L)

Trial Locations

Locations (1)

Department of Infectious Diseases, Aarhus University Hospital; 🇩🇰 Aarhus, Aarhus N, Denmark