Skip to main content
OpenTrials
Completed

NCT Number: NCT01524302

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pneumonia, Bacterial Bacterial Infections Bacterial Infections and Mycoses Community-acquired Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sparrow Hospital

Lansing, Michigan, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ceftaroline

Drug

600 mg Q12h

Other names: Teflaro

Levofloxacin

Drug

750 mg QD

Other names: Levaquin

Primary outcomes

  1. Serum Cidal Activity as Tested Against Staphylococcus Aureus Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)

    Time frame: 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 outcomes

  1. Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic Volume of Distribution Parameter in Community-Acquired Bacterial Pneumonia Patients

    Time frame: 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.

  2. Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Community-Acquired Bacterial Pneumonia Patients

    Time frame: 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.

  3. Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic (PK) Half Life Parameter in Community-Acquired Bacterial Pneumonia Patients

    Time frame: 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.

  4. Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Community-Acquired Bacterial Pneumonia Patients.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gary E. Stein, Pharm.D.

Other

Collaborators

  • Forest Laboratories

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Feb 1, 2012
Registry last updated
Apr 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.