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Beta-lactamase inhibitor

Ceftaroline for Injection for Gastroenteritis (cSSSI Trial)

Phase 3
Waitlist Available
Led By Ralph Corey, MD
Research Sponsored by Forest Laboratories
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first dose of study drug through toc visit
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

Eligible Conditions
  • Gastroenteritis
  • Bacterial Infection

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8-15 days after the end of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-15 days after the end of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical Cure Rate at Test of Cure (TOC) (MITT Population)
Secondary study objectives
Assess Safety

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ceftaroline for InjectionExperimental Treatment1 Intervention
Group II: IV Vancomycin and IV AztreonamActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceftaroline fosamil
FDA approved

Find a Location

Who is running the clinical trial?

Forest LaboratoriesLead Sponsor
337 Previous Clinical Trials
88,496 Total Patients Enrolled
Ralph Corey, MDPrincipal InvestigatorDuke University
~37 spots leftby Nov 2025
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