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NCT01524302 Clinical Trial

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

Pneumonia, Bacterial Clinical Trial

Official title:
Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia (CABP)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01524302
Other study ID # TEF-MD-02
Secondary ID
Status Completed
Phase Phase 4
First received January 30, 2012
Last updated April 7, 2015
Start date February 2012
Est. completion date April 2015

Study information
Verified date April 2015
Source Michigan State University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date April 2015
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ceftaroline
600 mg Q12h
• Levofloxacin
750 mg QD

Locations
Country Name City State
United States Sparrow Hospital Lansing Michigan

Sponsors (2)
Lead Sponsor Collaborator
Gary E. Stein, Pharm.D. Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacodynamics (time kill curves) To compare serum kill curves of ceftaroline and levofloxacin against drug-resistant strains of S. pneumoniae and S. aureus 1 year No
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