CompletedPhase 2

A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections

United States, Argentina, Bulgaria313 participantsStarted 2005-12

Plain-language summary

This 3 arm study will compare the efficacy and safety of beta-lactam with that of 'standard care' in patients with complicated skin and skin structure infections requiring hospitalization. Patients will be randomized to receive 1)beta-lactam 750mg iv q8h 2)beta-lactam 1500mg iv q8h or 3)'standard care' \[PRP (nafcillin or flucloxacillin) or vancomycin, plus aztreonam or ciprofloxacin\]. The anticipated time on study treatment is \<3 months and the target sample size is 100-500 individuals.

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: * adult patients, \>=18 years of age; * skin or skin structure infection requiring hospitalization; * clinical diagnosis of a skin or skin structure infection caused by bacteria known or suspected to be susceptible to the randomized study treatment; * material from site of infection is clinically purulent or seropurulent. Exclusion Criteria: * presenting with sustained shock (SBP\<90mm Hg for \> 2 hours, despite adequate fluid resuscitation); * known or suspected concomitant bacterial infection requiring antibiotic treatment; * skin infection or chronic non-healing ulcer of \> 2 weeks duration; * patients in whom surgery is the primary treatment.

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 cure rate.

Timeframe: Event driven

Trial details

NCT IDNCT00303589

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-10

View on ClinicalTrials.gov More Soft Tissue Infections trials