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

Gary E. Stein, Pharm.D.

Status and phase: Completed; Phase 4

Conditions: Community-acquired; Pneumonia, Bacterial

Treatments: Drug: Ceftaroline; Drug: Levofloxacin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01524302

TEF-MD-02

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Levofloxacin

Active Comparator group

Description:

Pharmacodynamics

Treatment:

Drug: Levofloxacin

Ceftaroline

Active Comparator group

Description:

Pharmacodynamics

Treatment:

Drug: Ceftaroline