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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Gary E. Stein, Pharm.D., Michigan State University
ClinicalTrials.gov Identifier:
NCT01524302
First received: January 30, 2012
Last updated: March 14, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Pneumonia, Bacterial
Community-acquired
Drug: Ceftaroline
Drug: Levofloxacin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia (CABP)

Resource links provided by NLM:


Further study details as provided by Michigan State University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 [ Time Frame: 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion ] [ Designated as safety issue: No ]
    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. [ Time Frame: 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: February 2012
Study Completion Date: April 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Levofloxacin
Pharmacodynamics
Drug: Levofloxacin
750 mg QD
Other Name: Levaquin
Active Comparator: Ceftaroline
Pharmacodynamics
Drug: Ceftaroline
600 mg Q12h
Other Name: Teflaro

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524302

Locations
United States, Michigan
Sparrow Hospital
Lansing, Michigan, United States
Sponsors and Collaborators
Gary E. Stein, Pharm.D.
Forest Laboratories
Investigators
Principal Investigator: Gary E Stein, Pharm.D. Michigan State University
  More Information

Responsible Party: Gary E. Stein, Pharm.D., Professor of Medicine and Pharmacology, Michigan State University
ClinicalTrials.gov Identifier: NCT01524302     History of Changes
Other Study ID Numbers: TEF-MD-02 
Study First Received: January 30, 2012
Results First Received: October 12, 2015
Last Updated: March 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Michigan State University:
pneumonia
ceftaroline
community-aquired

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Levofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 27, 2016