CompletedPhase 2

Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections

United States150 participantsStarted 2008-02

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Complicated skin and skin structure infection (cSSSI) * Require initial hospitalization, or treatment in an emergency room or urgent care setting Exclusion Criteria: * Hypersensitivity or allergic reaction to any ß-lactam, ceftaroline, linezolid, aztreonam, or to their components * Concomitant use of adrenergic or serotonergic agent * Uncomplicated skin and skin structure infection * Concomitant therapy with any drug known to exhibit a contraindicated drug-drug interaction * More than 24 hours of treatment with an antimicrobial within 96 hours before randomization * Known or suspected endocarditis, osteomyelitis, or septic arthritis * Severely impaired renal function * Evidence of significant hepatic, hematologic, or immunologic disease

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical Response at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population

Timeframe: Test of Cure Visit (8 to 15 days after end of therapy)

Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population

Timeframe: Test of Cure Visit (8 to 15 Days after end of therapy)

Trial details

NCT IDNCT00633152

SponsorForest Laboratories

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-07

Results submitted2012-07-25

View on ClinicalTrials.gov More Bacterial Infection trials