Evaluation of Ceftaroline Fosamil versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.

• Conditions: complicated bacterial skin and soft tissue infections; MedDRA version: 17.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-004013-16-DE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-09
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 765

Inclusion Criteria

1. Patient must provide a signed written informed consent prior to any study-specific procedures
2. Patient must be a male or female, aged 18 years and older
3. Patient must have one of the following cSSTIs:
- Cellulitis: a diffuse skin infection characterised by spreading areas of erythema, oedema, and/or induration of a minimum surface area of 75 cm2 (eg, minimum length of 10 cm and width of 7.5 cm)
- Traumatic or surgical wound infection: an infection characterised by purulent drainage/or collection from an injury-related wound or a surgical wound with surrounding erythema, oedema, and/or induration of a minimum surface area of 75 cm2 (eg, the shortest distance of redness, oedema, and/or induration extending at least 5 cm from the peripheral margin of the wound). Appropriate surgical intervention must be completed prior to the first dose of study drug or up to, at most, 48 hours after the first dose of study drug.
- Major cutaneous abscess: an infection characterised by a collection of pus within the dermis or deeper that is accompanied by erythema, oedema, and/or induration of a minimum surface area of 75 cm2 (eg, the shortest distance of redness, oedema, and/or induration extending at least 5 cm from the peripheral margin of the abscess). The abscess must undergo incision and drainage prior to the first dose of study drug or up to, at most, 48 hours after the first dose of study drug. The number of patients with major cutaneous abscesses will be limited to no more than30% of the study population.
- Burn infection: an infection characterised by purulent drainage, erythema, oedema, and/or induration of a minimum surface area of 75 cm2 (eg, the shortest distance of redness, oedema, and/or induration extending at least 5 cm from the peripheral margin of the burn infection). Burns must involve less than 15% of the body surface area and acquired within 7 days of hospitalisation. Appropriate surgical intervention must be completed prior to the first dose of study drug or up to, at most, 48 hours after the first dose of study drug.
4. Patients must demonstrate at least one of the following criteria (for the first 3 bullets, the criterion must be met within 24 hours prior to first dose of study drug):
- Temperature =38.0°C (100.4°F) or =36.0°C (96.8°F)
and/or
- White blood cells >12000 cells/mm3 or <4000 cells/mm3 or >10% band forms
(immature white blood cells)
and/or
- Heart rate >90 beats per minute and respiratory rate >20 breaths per minute after
10 minutes of rest
and/or
- One or more of the following comorbidities:
- Diabetes mellitus requiring drug therapy (note: patients with diabetic foot infections are excluded as per exclusion criterion #8)
- Stage 2 or 3 HIV infection (per Center for Disease control classification 2008) (note: patients with a CD4 count <150 cell/microliter within 6 months prior to first dose of study drug or suspected opportunistic infection are excluded)
- Chronic renal impairment (estimated creatinine clearance =20 mL/min to <50 mL/min) as calculated by the Cockcroft-Gault formula
- Cirrhosis with Child-Pugh Stage A or B (note: patients with Child-Pugh
Stage C are excluded)
- cSSTI below the knee associated with peripheral vascular disease diagnosed on the basis of any of the following: claudication at a distance of at least 20 meters; resting ankle-brachial index 0.3 to 0.8; prior femoral artery bypass grafting; or prior aortic aneurysm repair (note: patients with ulcers due to peripher

Exclusion Criteria

. Received systemic antibacterial drugs for greater than 24 hours within 96 hours prior to first dose of study drug
. Uncomplicated skin and skin structure infections, skin infections suspected to be caused by viral or fungal pathogens
. Diabetes, diabetic foot infections, decubitus ulcers, ulcers due to peripheral vascular disease
. Infection caused by human or animal bites, sternal wound infections, bone infection or arthritis due to an infection, critical limb ischemia of the affected limb
. Chronic liver disease or severe impaired renal function, severe low white blood cell count, burns on greater than 15% of total body surface area, necrotizing skin infection, amputation required of primary site of infection, sustained shock

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified