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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-58-0010 | Other Identifier | Datatilsynet, Denmark |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacokinetics Moxifloxacin | Patients with community-acquired pneumonia treated with moxifloxacin |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with community-acquired pneumonia, treated with moxifloxacin, admitted to the Department of Infectious diseases, Aarhus University Hospital, Denmark
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| Name | Affiliation | Role |
|---|---|---|
| Eskild Petersen, MD, Assoc. Prof., D.Sc. | Department of Infectious Diseases, Aarhus University Hospital, Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Infectious Diseases, Aarhus University Hospital | Aarhus | Aarhus N | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25666151 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pharmacokinetics Moxifloxacin | Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pharmacokinetics Moxifloxacin | Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Median | Inter-Quartile Range | mg/L | The second day of Moxifloxacin treatment |
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Serious and non-serious adverse events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pharmacokinetics Moxifloxacin | Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Kristina Öbrink-Hansen | Aarhus University Hospital, Department of infectious diseases | +4578452845 | krisoebr@rm.dk |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Whole blood
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Body weight | Median | Inter-Quartile Range | kg |
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| 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 model estimated median values of fAUC0-24 for the current study population were32.78 mg.hr/L (IQR 22.75; 47.31). respectively. | Posted | Median | Inter-Quartile Range | mg.hr/L | The second day of Moxifloxacin treatment |
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