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

NCT ID: NCT01524302

Last Updated: 2016-04-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-04-30

Brief Summary

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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

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Conditions

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Pneumonia, Bacterial Community-acquired

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levofloxacin

Pharmacodynamics

Group Type ACTIVE_COMPARATOR

Levofloxacin

Intervention Type DRUG

750 mg QD

Ceftaroline

Pharmacodynamics

Group Type ACTIVE_COMPARATOR

Ceftaroline

Intervention Type DRUG

600 mg Q12h

Interventions

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Ceftaroline

600 mg Q12h

Intervention Type DRUG

Levofloxacin

750 mg QD

Intervention Type DRUG

Other Intervention Names

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Teflaro Levaquin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role collaborator

Gary E. Stein, Pharm.D.

OTHER

Sponsor Role lead

Responsible Party

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Gary E. Stein, Pharm.D.

Professor of Medicine and Pharmacology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gary E Stein, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

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Sparrow Hospital

Lansing, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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TEF-MD-02

Identifier Type: -

Identifier Source: org_study_id

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