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PK Analysis of Moxifloxacin in the Treatment of CAP

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ClinicalTrials.gov Identifier: NCT01983839
Recruitment Status : Completed
First Posted : November 14, 2013
Results First Posted : April 6, 2015
Last Update Posted : April 6, 2015
Sponsor:
Information provided by (Responsible Party):
Kristina Öbrink-Hansen, University of Aarhus

Study Description
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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.

Condition or disease
Pneumonia

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 Design
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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Moxifloxacin Pharmacokinetic Profile and Efficacy Evaluation in the Empiric Treatment of Community-Acquired Pneumonia
Study Start Date : April 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Groups and Cohorts
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Group/Cohort
Pharmacokinetics Moxifloxacin
Patients with community-acquired pneumonia treated with moxifloxacin


Outcome Measures
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Primary Outcome Measures :
  1. 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)


  2. 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)



Biospecimen Retention:   Samples Without DNA
Whole blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • Patients with community-acquired pneumonia, treated with moxifloxacin

Exclusion Criteria:

  • Under 18 years of age
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983839


Locations
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Denmark
Department of Infectious Diseases, Aarhus University Hospital
Aarhus, Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
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Study Director: Eskild Petersen, MD, Assoc. Prof., D.Sc. Department of Infectious Diseases, Aarhus University Hospital, Denmark
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kristina Öbrink-Hansen, MD, University of Aarhus
ClinicalTrials.gov Identifier: NCT01983839    
Other Study ID Numbers: MOXI-274-13
2007-58-0010 ( Other Identifier: Datatilsynet, Denmark )
First Posted: November 14, 2013    Key Record Dates
Results First Posted: April 6, 2015
Last Update Posted: April 6, 2015
Last Verified: March 2015
Keywords provided by Kristina Öbrink-Hansen, University of Aarhus:
Moxifloxacin
Pneumonia
Pharmacokinetics
Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases