NCT01983839|CompletedResults
PK Analysis of Moxifloxacin in the Treatment of CAP
Moxifloxacin Pharmacokinetic Profile and Efficacy Evaluation in the Empiric Treatment of Community-Acquired Pneumonia
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Moxifloxacin Pharmacokinetic Profile and Efficacy Evaluation in the Empiric Treatment of Community-Acquired Pneumonia
Sponsor study identifier
Secondary identifiers
OTHER · Datatilsynet, Denmark
observational
18
1 country
1
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2014
Actual (reported)Study Completion
October 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
July 10, 2013
Actual (reported)November 14, 2013
Actual (reported)October 2014
Actual (reported)October 2014
Actual (reported)April 6, 2015
Actual (reported)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
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
Patients with community-acquired pneumonia treated with moxifloxacin
Patients with community-acquired pneumonia, treated with moxifloxacin, admitted to the Department of Infectious diseases, Aarhus University Hospital, Denmark
Department of Infectious Diseases, Aarhus University Hospital
Aarhus, Aarhus N, 8200, Denmark
Obrink-Hansen K, Hardlei TF, Brock B, Jensen-Fangel S, Kragh Thomsen M, Petersen E, Kreilgaard M. Moxifloxacin pharmacokinetic profile and efficacy evaluation in empiric treatment of community-acquired pneumonia. Antimicrob Agents Chemother. 2015 Apr;59(4):2398-404. doi: 10.1128/AAC.04659-14. Epub 2015 Feb 9.
Whole blood
Eskild Petersen, MD, Assoc. Prof., D.Sc.
Department of Infectious Diseases, Aarhus University Hospital, Denmark
18 participants (actual enrollment reported by the registry).
First Submitted
July 10, 2013
First Posted
November 14, 2013
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
October 2014
Actual (reported)Study Completion
October 2014
Actual (reported)Last Updated
April 6, 2015
Results First Posted
April 6, 2015
Record last verified: 2015-03
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Source: ClinicalTrials.gov.
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