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

Phase 4

Completed

• Conditions: Pneumonia, Bacterial; Community-acquired
• Interventions: Drug: Ceftaroline; Drug: Levofloxacin

• Registration Number: NCT01524302
• Lead Sponsor: Gary E. Stein, Pharm.D.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-30
• Study First Submitted QC: 2012-01-31
• Study Start: 2012-02
• Study First Posted: 2012-02-01
• Primary Completion: 2014-05
• Study Completion: 2015-04
• Results First Submitted: 2015-10-12
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-14
• Last Update Submitted: 2016-03-14
• Results First Posted: 2016-04-12
• Last Update Posted: 2016-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ceftaroline	Ceftaroline	Pharmacodynamics
Levofloxacin	Levofloxacin	Pharmacodynamics

Primary Outcome Measures

Name	Time	Method
Serum Cidal Activity as Tested Against Staphylococcus Aureus Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)	2 hour (levofloxacin) and 12 hour (ceftaroline) after receiving the drug	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

Name	Time	Method
Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic Volume of Distribution Parameter in Community-Acquired Bacterial Pneumonia Patients	2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion	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	2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion	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	2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion	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.	2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion	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.

Trial Locations

Locations (1)

Sparrow Hospital; 🇺🇸 Lansing, Michigan, United States