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

Complicated Skin and Soft Tissue Infection Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02202135
• Other study ID #: D3720C00001sub
• Status: Terminated
• Phase: Phase 3
• First received: July 25, 2014
• Last updated: September 1, 2017
• Start date: June 2014
• Est. completion date: January 2015

Study information

• Verified date: September 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Complicated Skin and Soft Tissue Infection
• Infection
• Soft Tissue Infections

Intervention

Drug:
• Ceftaroline fosamil
IV ceftaroline 600mg every 8 hours
• Vancomycin
IV vancomycin 15mg/kg every 12 hours
• Aztreonam
IV aztreonam 1 g every 8 hours

Locations

Country	Name	City	State
Argentina	Research site	Cordoba
Brazil	Research site	Passo Fundo	Rio Grande do Sul
Brazil	Research site	Salvador	Bahia
Brazil	Research site	Sao Jose do Rio Preto
Bulgaria	Research site	Pleven
Chile	Research site	Temuco
Croatia	Research site	Zagreb
Greece	Research site	Athens
Israel	Research site	Haifa
Israel	Research site	Ramat-Gan
Israel	Research site	Safed
Israel	Research site	Tel-Aviv
Italy	Research site	Milano
Poland	Research site	Lodz
Romania	Research site	Bucharest
South Africa	Research site	Dundee
South Africa	Research site	Worcester
Spain	Research site	Granada
Spain	Research site	Terrassa
Turkey	Research site	Ankara
Turkey	Research site	Diyarbakir
Turkey	Research site	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Forest Laboratories

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Response at TOC	Clinical cure is defined as resolution or improvement of signs and symptoms compared to baseline and no further antimicrobial therapy is necessary. Clinical failure is defined as any of the following: persistence or worsening in signs or symptoms, or requirement for concomitant antibiotic therapy, or requirement of an unplanned surgical intervention >48 hours after the first dose, or death caused by skin infection, or an AE leading to study drug discontinuation with alternative antimicrobial therapy required, or diagnosis of osteomyelitis >=8 days after the first dose.	7 to 20 days after last dose of study drug