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

• ClinicalTrials.gov Identifier: NCT02202135
• Recruitment Status: Terminated
• First Posted: July 28, 2014
• Results First Posted: March 31, 2016
• Last Update Posted: September 6, 2017
• Sponsor: Pfizer
• Collaborator: Forest Laboratories
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Complicated Skin and Soft Tissue Infection	Drug: Ceftaroline fosamil; Drug: Vancomycin; Drug: Aztreonam	Phase 3

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: June 2014
• Actual Primary Completion Date: January 2015
• Actual Study Completion Date: January 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ceftaroline fosamil; Patients will receive 600 mg of ceftaroline fosamil administered as a 120-minute intravenous infusion very 8 hours. Each dose will be infused in a volume of 250 mL over 120-minutes followed by aztreonam placebo in a volume of 100 mL infused over 30 minutes every 8 hours. In addition vancomycin placebo will be given in a volume of 250 mL infused over 120 minutes every 12 hours. Doses will be adjusted according to the patient's renal function.	Drug: Ceftaroline fosamil; IV ceftaroline 600mg every 8 hours
Active Comparator: Vancomycin plus aztreonam; Patients will receive combination of vancomycin plus aztreonam. Dose of vancomycin will be based on the patient's actual weight and will receive intravenous vancomycin every 12 hours with each dose infused over 120-minutes. Aztreonam dose will be 1 gram intravenously in a volume of 100 mL infused over 30 minutes every 8 hours. In addition, ceftaroline fosamil placebo will be given in a volume of 250 mL infused over 120 minutes every 8 hours. Doses adjusted according to patients renal function	Drug: Vancomycin; IV vancomycin 15mg/kg every 12 hours; Drug: Aztreonam; IV aztreonam 1 g every 8 hours

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Argentina

Research site

Cordoba, Argentina

Brazil

Research site

Salvador, Bahia, Brazil

Research site

Passo Fundo, Rio Grande do Sul, Brazil

Research site

Sao Jose do Rio Preto, Brazil

Bulgaria

Research site

Pleven, Bulgaria

Chile

Research site

Temuco, Chile

Croatia

Research site

Zagreb, Croatia

Greece

Research site

Athens, Greece

Israel

Research site

Haifa, Israel

Research site

Ramat-Gan, Israel

Research site

Safed, Israel

Research site

Tel-Aviv, Israel

Italy

Research site

Milano, Italy

Poland

Research site

Lodz, Poland

Romania

Research site

Bucharest, Romania

South Africa

Research site

Dundee, South Africa

Research site

Worcester, South Africa

Spain

Research site

Granada, Spain

Research site

Terrassa, Spain

Turkey

Research site

Ankara, Turkey

Research site

Diyarbakir, Turkey

Research site

Izmir, Turkey

Sponsors and Collaborators

Pfizer

Forest Laboratories

Investigators

• Study Director: David Melnick, MSD; AstraZeneca

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2016 Sep 1.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02202135
• Other Study ID Numbers: D3720C00001sub
• First Posted: July 28, 2014
• Results First Posted: March 31, 2016
• Last Update Posted: September 6, 2017
• Last Verified: September 2017

Keywords provided by Pfizer:

complicated skin and soft tissue infections (cSSTI); skin infection; ceftaroline; wound infection; cellulitis; burn infection; bacterial infection; vancomycin

Additional relevant MeSH terms:

Infections; Communicable Diseases; Soft Tissue Infections; Disease Attributes; Pathologic Processes; Vancomycin; Ceftaroline fosamil; Aztreonam; Anti-Bacterial Agents; Anti-Infective Agents