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Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus

NCT01645735 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2016-02-01

Study results available
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Summary

The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant Staphylococcus aureus (MRSA).

Conditions

Interventions

DRUG

Ceftaroline fosamil

Ceftaroline fosamil 600 mg IV over 60 minutes q8h; treatment duration 5 to 14 days

DRUG

Ceftriaxone plus vancomycin

Ceftriaxone 2g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Forest Laboratories Inc, an affiliate of Allergan plc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States
  • Georgia
  • Hungary
  • Poland
  • Romania
  • Russia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01645735 on ClinicalTrials.gov