Trial Outcomes & Findings for PK Analysis of Moxifloxacin in the Treatment of CAP (NCT NCT01983839)

Results Overview

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)

Recruitment status

COMPLETED

Target enrollment

18 participants

Primary outcome timeframe

The second day of Moxifloxacin treatment

Results posted on

2015-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PK Analysis of Moxifloxacin in the Treatment of CAP

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pharmacokinetics Moxifloxacin n=18 Participants 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.
Age, Categorical <=18 years	1 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=93 Participants
Age, Categorical >=65 years	3 Participants n=93 Participants
Age, Continuous	73 years n=93 Participants
Sex: Female, Male Female	10 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Body weight	72.6 kg n=93 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Pharmacokinetics Moxifloxacin n=18 Participants 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.
Total Peak Plasma Concentration (Cmax)	3.99 mg/L Interval 3.18 to 5.29

PRIMARY outcome

Timeframe: The second day of Moxifloxacin treatment

Population: The model estimated median values of fAUC0-24 for the current study population were32.78 mg.hr/L (IQR 22.75; 47.31). respectively.

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)

Outcome measures

Outcome measures
Measure	Pharmacokinetics Moxifloxacin n=18 Participants 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.
Area Under the Free Concentration-time Curve (fAUC0-24)	32.78 mg.hr/L Interval 22.75 to 47.31

Adverse Events

Pharmacokinetics Moxifloxacin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Kristina Öbrink-Hansen

Aarhus University Hospital, Department of infectious diseases

Phone: +4578452845

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place