search
Back to results

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

Primary Purpose

Pneumonia, Bacterial, Community-acquired

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ceftaroline
Levofloxacin
Sponsored by
Gary E. Stein, Pharm.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Bacterial focused on measuring pneumonia, ceftaroline, community-aquired

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • non-pregnant adults (≥ 18 years old) with suspected CABP admitted to the hospital for parenteral antibiotic therapy.
  • All patients will have a creatinine clearance (CrCl) >50 ml/min.

Exclusion Criteria:

  • pregnant or nursing patients,
  • allergy to penicillin/cephalosporin antibiotics,
  • allergy to fluoroquinolones,
  • renal or hepatic failure, or have received an antimicrobial in past 96h.
  • Patients who require antibiotics other than the study drugs will also be excluded.

Sites / Locations

  • Sparrow Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Levofloxacin

Ceftaroline

Arm Description

Pharmacodynamics

Pharmacodynamics

Outcomes

Primary Outcome Measures

Serum Cidal Activity as Tested Against Staphylococcus Aureus Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)
Serum cidal activity of serum collected at 2 hour (levofloxacin) and 12 hour (ceftaroline) time points from the patients was tested against methyicillin-sensitive staphylococcus aureus isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth). These staphylococcus aureus isolates had a range of minimum inhibitory concentrations (MIC) to Levofloxacin, 0.5, 1.0, 2.0, and 4.0 and the MIC's to Ceftaroline were 0.125, 0.19, 0.094, 0.094, respectively.

Secondary Outcome Measures

Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic Volume of Distribution Parameter in Community-Acquired Bacterial Pneumonia Patients
To determine the serum pharmacokinetic volume of distribution of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.
Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Community-Acquired Bacterial Pneumonia Patients
To determine the serum pharmacokinetic clearance of drug parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.
Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic (PK) Half Life Parameter in Community-Acquired Bacterial Pneumonia Patients
To determine the serum pharmacokinetic half life parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.
Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Community-Acquired Bacterial Pneumonia Patients.
To determine the serum pharmacokinetic Area Under Serum Curve parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.

Full Information

First Posted
January 30, 2012
Last Updated
March 14, 2016
Sponsor
Gary E. Stein, Pharm.D.
Collaborators
Forest Laboratories
search

1. Study Identification

Unique Protocol Identification Number
NCT01524302
Brief Title
Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia
Official Title
Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia (CABP)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gary E. Stein, Pharm.D.
Collaborators
Forest Laboratories

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will further analyze the use of ceftaroline for CABP and compare its potential to eradicate bacterial pathogens to standard fluoroquinolone therapy. The enhanced spectrum of ceftaroline compared to levofloxacin may be further highlighted from this investigation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Bacterial, Community-acquired
Keywords
pneumonia, ceftaroline, community-aquired

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levofloxacin
Arm Type
Active Comparator
Arm Description
Pharmacodynamics
Arm Title
Ceftaroline
Arm Type
Active Comparator
Arm Description
Pharmacodynamics
Intervention Type
Drug
Intervention Name(s)
Ceftaroline
Other Intervention Name(s)
Teflaro
Intervention Description
600 mg Q12h
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Other Intervention Name(s)
Levaquin
Intervention Description
750 mg QD
Primary Outcome Measure Information:
Title
Serum Cidal Activity as Tested Against Staphylococcus Aureus Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)
Description
Serum cidal activity of serum collected at 2 hour (levofloxacin) and 12 hour (ceftaroline) time points from the patients was tested against methyicillin-sensitive staphylococcus aureus isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth). These staphylococcus aureus isolates had a range of minimum inhibitory concentrations (MIC) to Levofloxacin, 0.5, 1.0, 2.0, and 4.0 and the MIC's to Ceftaroline were 0.125, 0.19, 0.094, 0.094, respectively.
Time Frame
2 hour (levofloxacin) and 12 hour (ceftaroline) after receiving the drug
Secondary Outcome Measure Information:
Title
Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic Volume of Distribution Parameter in Community-Acquired Bacterial Pneumonia Patients
Description
To determine the serum pharmacokinetic volume of distribution of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.
Time Frame
2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion
Title
Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Community-Acquired Bacterial Pneumonia Patients
Description
To determine the serum pharmacokinetic clearance of drug parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.
Time Frame
2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion
Title
Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic (PK) Half Life Parameter in Community-Acquired Bacterial Pneumonia Patients
Description
To determine the serum pharmacokinetic half life parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.
Time Frame
2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion
Title
Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Community-Acquired Bacterial Pneumonia Patients.
Description
To determine the serum pharmacokinetic Area Under Serum Curve parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.
Time Frame
2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: non-pregnant adults (≥ 18 years old) with suspected CABP admitted to the hospital for parenteral antibiotic therapy. All patients will have a creatinine clearance (CrCl) >50 ml/min. Exclusion Criteria: pregnant or nursing patients, allergy to penicillin/cephalosporin antibiotics, allergy to fluoroquinolones, renal or hepatic failure, or have received an antimicrobial in past 96h. Patients who require antibiotics other than the study drugs will also be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary E Stein, Pharm.D.
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sparrow Hospital
City
Lansing
State/Province
Michigan
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs