PK Analysis of Moxifloxacin in the Treatment of CAP

NCT ID: NCT01983839

Last Updated: 2015-04-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Pneumonia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pharmacokinetics Moxifloxacin

Patients with community-acquired pneumonia treated with moxifloxacin

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with community-acquired pneumonia, treated with moxifloxacin

Exclusion Criteria

* Under 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Kristina Öbrink-Hansen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eskild Petersen, MD, Assoc. Prof., D.Sc.

Role: STUDY_DIRECTOR

Department of Infectious Diseases, Aarhus University Hospital, Denmark

Locations

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Department of Infectious Diseases, Aarhus University Hospital

Aarhus, Aarhus N, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 25666151 (View on PubMed)

Other Identifiers

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2007-58-0010

Identifier Type: OTHER

Identifier Source: secondary_id

MOXI-274-13

Identifier Type: -

Identifier Source: org_study_id

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