Evaluation of Ceftaroline Fosamil Versus 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) 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499277
• Other study ID #: D3720C00001
• Secondary ID: 2011-004013-16
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2011
• Last updated: September 1, 2017
• Start date: May 2012
• 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: Completed
• Enrollment: 802
• Est. completion date: January 2015
• Est. primary completion date: June 2014
• 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

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	Córdoba
Argentina	Research Site	Santa Fe
Australia	Research Site	Parkville
Belgium	Research Site	Bruxelles
Brazil	Research Site	Belo Horizonte
Brazil	Research Site	Passo Fundo
Brazil	Research Site	Salvador
Brazil	Research Site	São José do Rio Preto
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Ruse
Bulgaria	Research Site	Sofia
Chile	Research Site	Temuco
Chile	Research Site	Viña del Mar
China	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
Croatia	Research Site	Slavonski Brod
Croatia	Research Site	Zagreb
Czechia	Research Site	Jihlava
Czechia	Research Site	Pardubice
France	Research Site	Orleans
Germany	Research Site	Dessau
Germany	Research Site	Hanau
Germany	Research Site	Heilbronn
Greece	Research Site	Athens
Hong Kong	Research Site	Kowloon
Hong Kong	Research Site	Pokfulam
Israel	Research Site	Haifa
Israel	Research Site	Ramat-Gan
Israel	Research Site	Safed
Israel	Research Site	Tel Aviv
Italy	Research Site	Milano
Korea, Republic of	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
Mexico	Research Site	Guadalajara
Peru	Research Site	Cusco
Peru	Research Site	Lima
Philippines	Research Site	Manila
Philippines	Research Site	Quezon City
Poland	Research Site	Lódz
Poland	Research Site	Lublin
Romania	Research Site	Bucharest
Russian Federation	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
South Africa	Research Site	Benoni
South Africa	Research Site	Cape Town
South Africa	Research Site	Johannesburg
South Africa	Research Site	Worcester
Spain	Research Site	Barcelona
Spain	Research Site	Granada
Spain	Research Site	Madrid
Spain	Research Site	Terrassa
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Taipei
Taiwan	Research Site	Yung Kang City
Turkey	Research Site	Ankara
Turkey	Research Site	Diyarbakir
Turkey	Research Site	Izmir
Ukraine	Research Site	Cherkasy
Ukraine	Research Site	Ivano-Frankivsk
Ukraine	Research Site	Kharkov
Ukraine	Research Site	Odesa
United States	Research Site	Bellaire	Texas
United States	Research Site	Carmel	Indiana
United States	Research Site	Chula Vista	California
United States	Research Site	Detroit	Michigan
United States	Research Site	Garden City	New York
United States	Research Site	Hazard	Kentucky
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Orlando	Florida
United States	Research Site	Springfield	Massachusetts
United States	Research Site	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Forest Laboratories

Countries where clinical trial is conducted

United States,  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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set	The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.	7 to 20 days after the last dose of study drug
Primary	Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set	The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.	7 to 20 days after the last dose of study drug
Secondary	Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set	Difference in microbiological favorable response rate at TOC in mMITT analysis set. Favorable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.	7 to 20 days after the last dose of study drug
Secondary	Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set	Difference in microbiological favorable response rate at TOC in ME. Favourable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.	7 to 20 days after the last dose of study drug
Secondary	Clinical Response at End of Treatment (EOT) in MITT Analysis Set	The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline.	On day of last dose of study drug (or + 1 day)
Secondary	Clinical Response at EOT in CE Analysis Set	The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline.	On day of last dose of study drug (or +1 day)
Secondary	Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC	The observed difference in the clinical relapse rates at LFU (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical relapse rate at LFU is measured by comparing a patient's signs and symptoms at late follow-up to those when they were cured at TOC.	21 to 42 days after the last dose of study drug
Secondary	Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set	The observed difference in the early success rates at 48 to 72 hours of treatment (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Early response rate as measured by comparing the participant's signs and symptoms at the 48-72 hour visit to those recorded at study baseline.	48 to 72 hours after first dose of study drug
Secondary	Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME	Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set	7 to 20 days after the last dose of study drug