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

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

Sponsors

Lead sponsor: Pfizer

Collaborator: Forest Laboratories

Source Pfizer
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

Overall Status Completed
Start Date May 2012
Completion Date January 2015
Primary Completion Date June 2014
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set 7 to 20 days after the last dose of study drug
Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set 7 to 20 days after the last dose of study drug
Secondary Outcome
Measure Time Frame
Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set 7 to 20 days after the last dose of study drug
Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set 7 to 20 days after the last dose of study drug
Clinical Response at End of Treatment (EOT) in MITT Analysis Set On day of last dose of study drug (or + 1 day)
Clinical Response at EOT in CE Analysis Set On day of last dose of study drug (or +1 day)
Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC 21 to 42 days after the last dose of study drug
Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set 48 to 72 hours after first dose of study drug
Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME 7 to 20 days after the last dose of study drug
Enrollment 802
Condition
Intervention

Intervention type: Drug

Intervention name: Ceftaroline fosamil

Description: IV ceftaroline 600mg every 8 hours

Arm group label: Ceftaroline fosamil

Intervention type: Drug

Intervention name: Vancomycin

Description: IV vancomycin 15mg/kg every 12 hours

Arm group label: Vancomycin plus aztreonam

Intervention type: Drug

Intervention name: Aztreonam

Description: IV aztreonam 1 g every 8 hours

Arm group label: Vancomycin plus aztreonam

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

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

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
David Melnick, MSD Study Director AstraZeneca
Location
facility
Research Site | Chula Vista, California, United States
Research Site | Orlando, Florida, United States
Research Site | West Palm Beach, Florida, United States
Research Site | Carmel, Indiana, United States
Research Site | Hazard, Kentucky, United States
Research Site | Springfield, Massachusetts, United States
Research Site | Detroit, Michigan, United States
Research Site | Las Vegas, Nevada, United States
Research Site | Garden City, New York, United States
Research Site | Bellaire, Texas, United States
Research Site | Córdoba, Argentina
Research Site | Santa Fe, Argentina
Research Site | Parkville, Australia
Research Site | Bruxelles, Belgium
Research Site | Belo Horizonte, Brazil
Research Site | Passo Fundo, Brazil
Research Site | Salvador, Brazil
Research Site | São José do Rio Preto, Brazil
Research Site | Pleven, Bulgaria
Research Site | Ruse, Bulgaria
Research Site | Sofia, Bulgaria
Research Site | Temuco, Chile
Research Site | Viña del Mar, Chile
Research Site | Beijing, China
Research Site | Changchun, China
Research Site | Changsha, China
Research Site | Chengdu, China
Research Site | Chongqing, China
Research Site | Fuzhou, China
Research Site | Guangzhou, China
Research Site | Haikou, China
Research Site | Nanning, China
Research Site | Qingdao, China
Research Site | Shanghai, China
Research Site | Shenyang, China
Research Site | Shijiazhuang, China
Research Site | Wuhan, China
Research Site | Xi'an, China
Research Site | Slavonski Brod, Croatia
Research Site | Zagreb, Croatia
Research Site | Jihlava, Czechia
Research Site | Pardubice, Czechia
Research Site | Orleans, France
Research Site | Dessau, Germany
Research Site | Hanau, Germany
Research Site | Heilbronn, Germany
Research Site | Athens, Greece
Research Site | Kowloon, Hong Kong
Research Site | Pokfulam, Hong Kong
Research Site | Haifa, Israel
Research Site | Ramat-Gan, Israel
Research Site | Safed, Israel
Research Site | Tel Aviv, Israel
Research Site | Milano, Italy
Research Site | Ansan, Korea, Republic of
Research Site | Deagu, Korea, Republic of
Research Site | Incheon, Korea, Republic of
Research Site | Seoul, Korea, Republic of
Research Site | Won-ju, Korea, Republic of
Research Site | Guadalajara, Mexico
Research Site | Cusco, Peru
Research Site | Lima, Peru
Research Site | Manila, Philippines
Research Site | Quezon City, Philippines
Research Site | Lublin, Poland
Research Site | Łódź, Poland
Research Site | Bucharest, Romania
Research Site | Moscow, Russian Federation
Research Site | Perm, Russian Federation
Research Site | Saint Petersburg, Russian Federation
Research Site | Smolensk, Russian Federation
Research Site | Vsevolozhsk, Russian Federation
Research Site | Yaroslavl, Russian Federation
Research Site | Benoni, South Africa
Research Site | Cape Town, South Africa
Research Site | Johannesburg, South Africa
Research Site | Worcester, South Africa
Research Site | Barcelona, Spain
Research Site | Granada, Spain
Research Site | Madrid, Spain
Research Site | Terrassa, Spain
Research Site | Kaohsiung, Taiwan
Research Site | Taipei, Taiwan
Research Site | Yung Kang City, Taiwan
Research Site | Ankara, Turkey
Research Site | Diyarbakir, Turkey
Research Site | Izmir, Turkey
Research Site | Cherkasy, Ukraine
Research Site | Ivano-Frankivsk, Ukraine
Research Site | Kharkov, Ukraine
Research Site | Odesa, Ukraine
Location Countries

Argentina

Australia

Belgium

Brazil

Bulgaria

Chile

China

Croatia

Czechia

France

Germany

Greece

Hong Kong

Israel

Italy

Korea, Republic of

Mexico

Peru

Philippines

Poland

Romania

Russian Federation

South Africa

Spain

Taiwan

Turkey

Ukraine

United States

Verification Date

September 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Ceftaroline fosamil

Arm group type: Experimental

Description: 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.

Arm group label: Vancomycin plus aztreonam

Arm group type: Active Comparator

Description: 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

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov