Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections (NCT03137173) | Clinical Trial Compass
CompletedPhase 3
Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections
United States679 participantsStarted 2018-02-19
Plain-language summary
This was a randomized, double-blind, active-controlled, parallel-group, multicenter study in adult hospitalized patients to establish the safety and efficacy of ceftobiprole medocaril compared with vancomycin plus aztreonam in the treatment of acute bacterial skin and skin structure infections (ABSSSIs).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female, aged ≥18 years.
✓. Diagnosis of ABSSSI, meeting at least one of the definitions in (a) to (c) below. Local symptoms must have started within the 7 days prior to the Screening visit:
✓. Cellulitis/erysipelas, defined as a diffuse skin infection characterized by all of the following within 24 hours:
✓. Major cutaneous abscess, defined as infection characterized by a collection of pus within the dermis or deeper that is apparent upon visual examination before or after therapeutic intervention and is accompanied by all of the following within 24 hours:
✓. Wound infection, defined as infection of any apparent break in the skin characterized by at least one of the following:
✓. At least one of the following regional or systemic signs of infection at the Screening visit:
✓. Lymph node tenderness and volume increase, or palpable lymph node proximal to the primary ABSSSI.
✕. Use of any systemic antibacterial treatment within 14 days, or topical antibacterial administration on the primary lesion within 96 hours, before first infusion of study drug.
✕. Contraindication to the administration of either of the study treatments, including known clinically-relevant hypersensitivity to related antibacterial treatments (e.g., beta-lactam and glycopeptide antibiotics), or to metronidazole if required as adjunctive therapy.
What they're measuring
1
Early Clinical Response
Timeframe: 48-72 hours after start of study drug treatment
✕. Participation in any other clinical study within the 30 days prior to randomization, or any prior participation in this study.
✕. The primary ABSSSI is an uncomplicated skin and skin structure infection, such as furuncles, minor abscesses (area of suppuration not surrounded by cellulitis/erysipelas), impetiginous lesions, superficial or limited cellulitis/erysipelas, or minor wound infections (e.g., stitch abscesses).
✕. The primary ABSSSI is due to, or associated with, any of the following:
✕. Diabetic foot infection, gangrene, or perianal abscess.
✕. Concomitant infection at another site (e.g., septic arthritis, endocarditis, osteomyelitis), not including a secondary ABSSSI lesion.