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Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections

NCT01499277 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 802

Last updated 2017-09-06

Study results available
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Summary

The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.

Conditions

  • Complicated Skin and Soft Tissue Infection

Interventions

DRUG

Ceftaroline fosamil

IV ceftaroline 600mg every 8 hours

DRUG

Vancomycin

IV vancomycin 15mg/kg every 12 hours

DRUG

Aztreonam

IV aztreonam 1 g every 8 hours

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • David Melnick, MSD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-06-30
Completion
2015-01-31

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Chile
  • China
  • Croatia
  • Czechia
  • France
  • Germany
  • Greece
  • Hong Kong
  • Israel
  • Italy
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Romania
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
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 NCT01499277 on ClinicalTrials.gov