PK Analysis of Moxifloxacin in the Treatment of CAP

Pneumonia Clinical Trial

Official title:

Moxifloxacin Pharmacokinetic Profile and Efficacy Evaluation in the Empiric Treatment of Community-Acquired Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983839
• Other study ID #: MOXI-274-13
• Secondary ID: 2007-58-0010
• Status: Completed
• Phase: N/A
• First received: July 10, 2013
• Last updated: March 25, 2015
• Start date: April 2013
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with community-acquired pneumonia, treated with moxifloxacin

Exclusion Criteria:

• Under 18 years of age

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Pneumonia

Locations

Country	Name	City	State
Denmark	Department of Infectious Diseases, Aarhus University Hospital	Aarhus	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Peak Plasma Concentration (Cmax)	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)	The second day of Moxifloxacin treatment	No
Primary	Area Under the Free Concentration-time Curve (fAUC0-24)	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)	The second day of Moxifloxacin treatment	No