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

Completed · Phase 2

Conditions studied: Soft Tissue Infections

In brief

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.

Key facts

Study ID

NCT00303589

Run by

Hoffmann-La Roche

People needed

313

Starts

2005-12-01

Expected to finish

2007-10-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Melbourne, Florida, United States
• Study site — Miami Beach, Florida, United States
• Study site — Detroit, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Ciudadela, Argentina
• Study site — Córdoba, Argentina
• Study site — Córdoba, Argentina
• Study site — El Palomar, Argentina
• Study site — Entre Ríos, Argentina
• Study site — Granadero Baigorria, Argentina
• Study site — Merlo, Argentina
• Study site — Neuquén, Argentina
• Study site — Rosario, Argentina
• Study site — Rosario, Argentina
• Study site — Santa Fe, Argentina
• Study site — Pleven, Bulgaria
• Study site — Plovdiv, Bulgaria
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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