NCT01524302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1 year until next milestone

Results Posted

Study results publicly available

April 12, 2016

Completed
Last Updated

April 12, 2016

Status Verified

March 1, 2016

Enrollment Period

2.2 years

First QC Date

January 30, 2012

Results QC Date

October 12, 2015

Last Update Submit

March 14, 2016

Conditions

Pneumonia, BacterialCommunity-acquired

Keywords

pneumoniaceftarolinecommunity-aquired

Outcome Measures

Primary Outcomes (1)

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

    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.

    2 hour (levofloxacin) and 12 hour (ceftaroline) after receiving the drug

Secondary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Levofloxacin

ACTIVE COMPARATOR

Pharmacodynamics

Drug: Levofloxacin

Ceftaroline

ACTIVE COMPARATOR

Pharmacodynamics

Drug: Ceftaroline

Interventions

CeftarolineDRUG

600 mg Q12h

Also known as: Teflaro
Ceftaroline
LevofloxacinDRUG

750 mg QD

Also known as: Levaquin
Levofloxacin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sparrow Hospital

Lansing, Michigan, United States

Location

MeSH Terms

Conditions

Pneumonia, BacterialPneumonia

Interventions

CeftarolineLevofloxacin

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsOfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolines

Results Point of Contact

Title
Dr. Gary E. Stein
Organization
Michigan State University
steing@msu.edu
517-353-5126

Study Officials

  • Gary E Stein, Pharm.D.

    Michigan State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine and Pharmacology

Study Record Dates

First Submitted

January 30, 2012

First Posted

February 1, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2014

Study Completion

April 1, 2015

Last Updated

April 12, 2016

Results First Posted

April 12, 2016

Record last verified: 2016-03

Locations

US(1)