PK Analysis of Moxifloxacin in the Treatment of CAP
March 25, 2015 updated by: Kristina Öbrink-Hansen, University of Aarhus
Moxifloxacin Pharmacokinetic Profile and Efficacy Evaluation in the Empiric Treatment of Community-Acquired Pneumonia
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
18
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aarhus N
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Aarhus, Aarhus N, Denmark, 8200
- Department of Infectious Diseases, Aarhus University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with community-acquired pneumonia, treated with moxifloxacin, admitted to the Department of Infectious diseases, Aarhus University Hospital, Denmark
Description
Inclusion Criteria:
- Patients with community-acquired pneumonia, treated with moxifloxacin
Exclusion Criteria:
- Under 18 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
|---|
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Pharmacokinetics Moxifloxacin
Patients with community-acquired pneumonia treated with moxifloxacin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Peak Plasma Concentration (Cmax)
Time Frame: 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) |
The second day of Moxifloxacin treatment
|
|
Area Under the Free Concentration-time Curve (fAUC0-24)
Time Frame: 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) |
The second day of Moxifloxacin treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Eskild Petersen, MD, Assoc. Prof., D.Sc., Department of Infectious Diseases, Aarhus University Hospital, Denmark
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
July 10, 2013
First Submitted That Met QC Criteria
November 13, 2013
First Posted (Estimate)
November 14, 2013
Study Record Updates
Last Update Posted (Estimate)
April 6, 2015
Last Update Submitted That Met QC Criteria
March 25, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOXI-274-13
- 2007-58-0010 (Other Identifier: Data tilsynet)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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