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Completed

NCT Number: NCT00423657

Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

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Key information

Conditions

Bacterial Infections Abscess Bacterial Infections and Mycoses Cellulitis Connective Tissue Diseases Gram-Positive Bacterial Infections Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcal Skin Infections Suppuration Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site, Buenos Aires, Argentina

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About this study

Additional purpose of this study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease.

Exclusion criteria

  • Prior treatment of current complicated skin and skin structure infection (cSSSI) with an antimicrobial.
  • Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.

Treatment and study plan

ceftaroline

Drug

600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days

Other names: Experimental

vancomycin plus aztreonam

Drug

vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days.

Other names: Active Comparator

Placebo

Drug

Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.

Primary outcomes

  1. Clinical Cure Rate at Test of Cure (TOC) (MITT Population)

    Time frame: 8-15 days after last dose of study drug administration

    Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary.

    Failure: Requirement of alternative antimicrobial therapy for primary infection of complicated skin and skin structure infection (cSSSI) due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI.

    Indeterminate: Inability to determine an outcome

  2. The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations.

    Time frame: 8-15 days after last dose of study drug

Secondary outcomes

  1. To Evaluate the Microbiological Success Rate at the TOC Visit

    Time frame: 8-15 days after the last dose of study drug

  2. To Evaluate the Clinical Response at the End of Therapy (EOT) Visit

    Time frame: last day of study drug administration

  3. To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit

    Time frame: 8-15 days after last dose of study drug

  4. To Evaluate Clinical Relapse at the Late Follow Up (LFU) Visit

    Time frame: 21 to 35 days after the last dose of study drug

  5. To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit

    Time frame: 21-35 days after last dose of study drug

  6. To Evaluate Safety

    Time frame: first study drug dose through TOC

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection (cSSSI)

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 18, 2007
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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