ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01524302
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : April 12, 2016
Last Update Posted : April 12, 2016
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Gary E. Stein, Pharm.D., Michigan State University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Pneumonia, Bacterial
Community-acquired
Interventions: Drug: Ceftaroline
Drug: Levofloxacin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Levofloxacin

Pharmacodynamics

Levofloxacin: 750 mg QD

Ceftaroline

Pharmacodynamics

Ceftaroline: 600 mg Q12h


Participant Flow:   Overall Study
    Levofloxacin   Ceftaroline
STARTED   6   6 
COMPLETED   6   6 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Levofloxacin

Pharmacodynamics

Levofloxacin: 750 mg QD

Ceftaroline

Pharmacodynamics

Ceftaroline: 600 mg Q12h

Total Total of all reporting groups

Baseline Measures
   Levofloxacin   Ceftaroline   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   12 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   3   6   9 
>=65 years   3   0   3 
Age 
[Units: Years]
Mean (Full Range)
 56 
 (26 to 72) 
 52 
 (40 to 61) 
 54 
 (26 to 72) 
Gender 
[Units: Participants]
     
Female   4   5   9 
Male   2   1   3 
Region of Enrollment 
[Units: Participants]
     
United States   6   6   12 


  Outcome Measures

1.  Primary:   Serum Cidal Activity as Tested Against Staphylococcus Aureus Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)   [ Time Frame: 2 hour (levofloxacin) and 12 hour (ceftaroline) after receiving the drug ]

2.  Secondary:   Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic Volume of Distribution Parameter in Community-Acquired Bacterial Pneumonia Patients   [ Time Frame: 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion ]

3.  Secondary:   Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Community-Acquired Bacterial Pneumonia Patients   [ Time Frame: 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion ]

4.  Secondary:   Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic (PK) Half Life Parameter in Community-Acquired Bacterial Pneumonia Patients   [ Time Frame: 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion ]

5.  Secondary:   Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Community-Acquired Bacterial Pneumonia Patients.   [ Time Frame: 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Gary E. Stein
Organization: Michigan State University
phone: 517-353-5126
e-mail: steing@msu.edu



Responsible Party: Gary E. Stein, Pharm.D., Michigan State University
ClinicalTrials.gov Identifier: NCT01524302     History of Changes
Other Study ID Numbers: TEF-MD-02
First Submitted: January 30, 2012
First Posted: February 1, 2012
Results First Submitted: October 12, 2015
Results First Posted: April 12, 2016
Last Update Posted: April 12, 2016