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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 Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Cross-Sectional
Condition Pneumonia
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pharmacokinetics Moxifloxacin
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 18
Completed 18
Not Completed 0
Arm/Group Title Pharmacokinetics Moxifloxacin
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
1
   5.6%
Between 18 and 65 years
14
  77.8%
>=65 years
3
  16.7%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 18 participants
73
(66 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
10
  55.6%
Male
8
  44.4%
Body weight  
Median (Inter-Quartile Range)
Unit of measure:  Kg
Number Analyzed 18 participants
72.6
(64.1 to 80.6)
1.Primary Outcome
Title Total Peak Plasma Concentration (Cmax)
Time Frame The second day of Moxifloxacin treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pharmacokinetics Moxifloxacin
Hide Arm/Group Description:

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.

The model estimated median values of total Cmax and fAUC0-24 for the current study population were3.99 mg/L (IQR 3.19; 5.29) and 32.78 mg.hr/L (IQR 22.75; 47.31). respectively.

Overall Number of Participants Analyzed 18
Median (Inter-Quartile Range)
Unit of Measure: mg/L
3.99
(3.18 to 5.29)
2.Primary Outcome
Title Area Under the Free Concentration-time Curve (fAUC0-24)
Time Frame The second day of Moxifloxacin treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The model estimated median values of fAUC0-24 for the current study population were32.78 mg.hr/L (IQR 22.75; 47.31). respectively.
Arm/Group Title Pharmacokinetics Moxifloxacin
Hide Arm/Group Description:

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.

The model estimated median values of total Cmax and fAUC0-24 for the current study population were3.99 mg/L (IQR 3.19; 5.29) and 32.78 mg.hr/L (IQR 22.75; 47.31). respectively.

Overall Number of Participants Analyzed 18
Median (Inter-Quartile Range)
Unit of Measure: mg.hr/L
32.78
(22.75 to 47.31)
Time Frame [Not Specified]
Adverse Event Reporting Description Serious and non-serious adverse events were not collected.
 
Arm/Group Title Pharmacokinetics Moxifloxacin
Hide Arm/Group Description 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.
All-Cause Mortality
Pharmacokinetics Moxifloxacin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pharmacokinetics Moxifloxacin
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Pharmacokinetics Moxifloxacin
Affected / at Risk (%)
Total   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Kristina Öbrink-Hansen
Organization: Aarhus University Hospital, Department of infectious diseases
Phone: +4578452845
EMail: krisoebr@rm.dk
Layout table for additonal information
Responsible Party: Kristina Öbrink-Hansen, University of Aarhus
ClinicalTrials.gov Identifier: NCT01983839     History of Changes
Other Study ID Numbers: MOXI-274-13
2007-58-0010 ( Other Identifier: Datatilsynet, Denmark )
First Submitted: July 10, 2013
First Posted: November 14, 2013
Results First Submitted: February 10, 2015
Results First Posted: April 6, 2015
Last Update Posted: April 6, 2015