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

This study is currently recruiting participants.
Verified January 2014 by AstraZeneca
Sponsor:
Collaborator:
Cerexa, Inc.
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01499277
First received: December 16, 2011
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Complicated Skin and Soft Tissue Infection
Drug: Ceftaroline fosamil
Drug: Vancomycin
Drug: Aztreonam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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) 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Clinical Cure as Measured by Comparing the Participants Signs and Symptoms at the Test of Cure (TOC) Visit to Those Recorded at Study Baseline in both the modified Intent-To-Treat and the Clinically Evaluable analysis sets [ Time Frame: 8 to 15 days after the last dose of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The clinical cure rate in the modified intent-to-treat and clinically evaluable analysis sets [ Time Frame: within 24 hours of completion of last infusion of study drug ] [ Designated as safety issue: No ]
  • The per-patient microbiological favorable response in the microbiological modified intent-to-treat and microbiologically evaluable analysis sets [ Time Frame: within 24 hours of completion of the last infusion of study drug and 8 to 15 days after the last dose of study drug ] [ Designated as safety issue: No ]
  • The clinical cure rate and per-pathogen microbiological favorable response by baseline pathogen in the microbiological modified intent-to-treat and microbiologically evaluable analysis sets [ Time Frame: 8 to 15 days after the last dose of study drug ] [ Designated as safety issue: No ]
  • Clinical relapse in patients who were clinically cured at the test of cure visit in the clinically evaluable analysis set [ Time Frame: 21 to 35 days after the last dose of study drug ] [ Designated as safety issue: No ]
  • Re-infection and recurrence rate in patients who were microbiological successes at the test of cure visits in the microbiologically evaluable analysis set [ Time Frame: 21 to 35 days after the last dose of study drug ] [ Designated as safety issue: No ]
  • Super-infection rate in the microbiologically evaluable analysis set [ Time Frame: within 24 hours of completion of the last infusion of study drug ] [ Designated as safety issue: No ]
  • New infection rate in the microbiologically evaluable analysis set [ Time Frame: 8 to 15 days after the last dose of study drug ] [ Designated as safety issue: No ]
  • Colonization rate in patients who had a clinical assessment in the microbiologically evaluable analysis set [ Time Frame: within 24 hours of completion of the last infusion of study drug or 8 to 15 days after the last dose of study drug ] [ Designated as safety issue: No ]
  • Early response rate in the modified intent-to-treat and clinically evaluable analysis sets [ Time Frame: at 48 to 72 hours of treatment ] [ Designated as safety issue: No ]
  • The safety and tolerability by incidence and severity of adverse events, vital signs, clinical laboratory tests, ECGs and physical exam [ Time Frame: study duration (26 days up to 51 days) ] [ Designated as safety issue: Yes ]
  • Description of population pharmacokinetics of ceftaroline and ceftaroline fosamil in this patient population. [ Time Frame: Within 15 minutes prior to start of infusion, 120 min +/- 5 min following start of infusion through end of infusion, 3-5 hours after start of infusion, and 6-8 hours after start of study drug and prior to next infusion ] [ Designated as safety issue: No ]
  • PK profiles, including Cmax, Tmax, t½λz, AUC, plasma clearance, Vz, Vss, and mean residence time, of ceftaroline, ceftaroline fosamil and ceftaroline M-1 with intensive sampling in a subset of about 45 patients [ Time Frame: Within 15 minutes prior to start of infusion and following the start of infusion at 60, 90, 115, 125, 135 minutes and 2.5, 3, 4, 5, 6, and 8 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 765
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499277

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 ClinicalTrialTransparency@astrazeneca.com
Contact: Noaman Akhtar 1-910-558-4248 Noaman.Akhtar@ppdi.com

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Locations
United States, California
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Blackpool, United Kingdom
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Cottingham, United Kingdom
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Winchester, United Kingdom
Sponsors and Collaborators
AstraZeneca
Cerexa, Inc.
Investigators
Study Director: David Melnick, MSD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01499277     History of Changes
Other Study ID Numbers: D3720C00001, 2011-004013-16
Study First Received: December 16, 2011
Last Updated: January 24, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Chile: Instituto de Salud Publica de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Croatia: Ministry of Health and Social Care
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hong Kong: Department of Health
Israel: Ministry of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Peru: Ministry of Health
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Spanish Agency of Medicines
Taiwan : Food and Drug Administration
Thailand: Food and Drug Administration
Turkey: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by AstraZeneca:
complicated skin and soft tissue infections (cSSTI)
skin infection
ceftaroline
wound infection
cellulitis
burn infection
bacterial infection
vancomycin

Additional relevant MeSH terms:
Skin Diseases, Infectious
Soft Tissue Infections
Infection
Skin Diseases
Aztreonam
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014