NCT01983839

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
6 months until next milestone

Results Posted

Study results publicly available

April 6, 2015

Completed
Last Updated

April 6, 2015

Status Verified

March 1, 2015

Enrollment Period

1.5 years

First QC Date

July 10, 2013

Results QC Date

February 10, 2015

Last Update Submit

March 25, 2015

Conditions

Pneumonia

Keywords

MoxifloxacinPneumoniaPharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Pharmacokinetics Moxifloxacin

Patients with community-acquired pneumonia treated with moxifloxacin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with community-acquired pneumonia, treated with moxifloxacin, admitted to the Department of Infectious diseases, Aarhus University Hospital, Denmark

You may qualify if:

  • Patients with community-acquired pneumonia, treated with moxifloxacin

You may not qualify if:

  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Infectious Diseases, Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 25666151DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Dr Kristina Öbrink-Hansen
Organization
Aarhus University Hospital, Department of infectious diseases
krisoebr@rm.dk
+4578452845

Study Officials

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

    Department of Infectious Diseases, Aarhus University Hospital, Denmark

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 10, 2013

First Posted

November 14, 2013

Study Start

April 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

April 6, 2015

Results First Posted

April 6, 2015

Record last verified: 2015-03

Locations

DK(1)