Phase 4
N=12
Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia
Pneumonia, Bacterial · Community-acquired
Bottom Line
View on ClinicalTrials.gov: NCT01524302 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Serum Cidal Activity as Tested Against Staphylococcus Aureus Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth) — 2; 4; 1; 1 Log inhibition
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ceftaroline (Drug); Levofloxacin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gary E. Stein, Pharm.D.
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Cidal Activity as Tested Against Staphylococcus Aureus Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth) |
2; 4; 1; 1; 3; 5 | — |
| SECONDARY Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic Volume of Distribution Parameter in Community-Acquired Bacterial Pneumonia Patients |
92; 20.6 | — |
| SECONDARY Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Community-Acquired Bacterial Pneumonia Patients |
9.4; 7.3 | — |
| SECONDARY Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic (PK) Half Life Parameter in Community-Acquired Bacterial Pneumonia Patients |
7.2; 1.9 | — |
| SECONDARY Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Community-Acquired Bacterial Pneumonia Patients. |
87; 90 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01524302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.