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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02202135
• Date of registration: 25/07/2014
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.
• Scientific 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.
• Date of first enrolment: June 2014
• Target sample size: 4
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02202135
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Brazil, Bulgaria, Chile, Croatia, Greece, Israel, Italy, Poland, Romania, South Africa, Spain, Turkey

Contacts

• Name: David Melnick, MSD
• Affiliation: AstraZeneca

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Complicated Skin and Soft Tissue Infection

Intervention(s)

Drug: Ceftaroline fosamil

Drug: Vancomycin

Drug: Aztreonam

Primary Outcome(s)

Clinical Response at TOC [Time Frame: 7 to 20 days after last dose of study drug]

Secondary ID(s)

D3720C00001sub

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Forest Laboratories

Results

• Results available: Yes
• Date Posted: 31/03/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02202135