Clinical trial NCT02202135: Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.
Official title: A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg Every 8 Hours) vs Vancomycin Plus Aztreonam in the Treatment of Patients With Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Complicated Skin and Soft Tissue Infection
Keywords: complicated skin and soft tissue infections (cSSTI)
skin infection
ceftaroline
wound infection
cellulitis
burn infection
bacterial infection
vancomycin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Forest Laboratories
First posted: 2014-07-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.

Detailed description: A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients with Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18 years or older - Complicated skin and skin structure infection (cSSTI) - Infection of sufficient severity to warrant hospitalization - Infection of sufficient severity such that it is expected to require at least 5 days of intravenous antibiotic therapy. patients must have a positive culture for MRSA that has been obtained from the skin infection site and/or blood samples at any time within the 72hrs before the first dose.

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 - 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

Primary outcomes:
measure: Clinical Response at TOC
timeFrame: 7 to 20 days after last dose of study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Cordoba
country: Argentina
facility: Research site
city: Salvador
country: Brazil
facility: Research site
state: Bahia
city: Passo Fundo
country: Brazil
facility: Research site
state: Rio Grande do Sul
city: Sao Jose do Rio Preto
country: Brazil
facility: Research site
city: Pleven
country: Bulgaria
facility: Research site
city: Temuco
country: Chile
facility: Research site
city: Zagreb
country: Croatia
facility: Research site
city: Athens
country: Greece
facility: Research site
city: Haifa
country: Israel
facility: Research site
city: Ramat-Gan
country: Israel
facility: Research site
city: Safed
country: Israel
facility: Research site
city: Tel-Aviv
country: Israel
facility: Research site
city: Milano
country: Italy
facility: Research site
city: Lodz
country: Poland
facility: Research site
city: Bucharest
country: Romania
facility: Research site
city: Dundee
country: South Africa
facility: Research site
city: Worcester
country: South Africa
facility: Research site
city: Granada
country: Spain
facility: Research site
city: Terrassa
country: Spain
facility: Research site
city: Ankara
country: Turkey
facility: Research site
city: Diyarbakir
country: Turkey
facility: Research site
city: Izmir
country: Turkey
facility: Research site
Study officials:
affiliation: AstraZeneca
name: David Melnick, MSD
role: STUDY_DIRECTOR
References:
citation: Dryden M, Zhang Y, Wilson D, Iaconis JP, Gonzalez J. A Phase III, randomized, controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in patients with complicated skin and soft tissue infection with systemic inflammatory response or underlying comorbidities. J Antimicrob Chemother. 2016 Dec;71(12):3575-3584. doi: 10.1093/jac/dkw333. Epub 2016 Sep 1.