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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Michigan State University
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: April 1, 2014
Last verified: April 2014
  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:
  • Pharmacodynamics (time kill curves) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To compare serum kill curves of ceftaroline and levofloxacin against drug-resistant strains of S. pneumoniae and S. aureus


Estimated Enrollment: 16
Study Start Date: February 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 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
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

Contacts
Contact: Gary E Stein, Pharm.D. 517-353-5126 steing@msu.edu
Contact: Curtis Smith, Pharm.D. 517-364-3579

Locations
United States, Michigan
Sparrow Hospital Recruiting
Lansing, Michigan, United States
Contact: Gary E Stein, Pharm.D.    517-353-5126    steing@msu.edu   
Contact: Curtis Smith, Pharm.D.    517-364-3579      
Sponsors and Collaborators
Gary E. Stein, Pharm.D.
Forest Laboratories
Investigators
Principal Investigator: Gary E Stein, Pharm.D. Michigan State University
  More Information

No publications provided

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
Last Updated: April 1, 2014
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
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Levofloxacin
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 20, 2014