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Completed

NCT Number: NCT00509106

Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia

The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.

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Key information

Conditions

Bacterial Pneumonia Bacterial Infections Bacterial Infections and Mycoses Community-Acquired Infections Community-Acquired Pneumonia Gram-Negative Bacterial Infections Haemophilus Infections Infections Lung Diseases Pasteurellaceae Infections Pneumonia Pneumonia, Bacterial Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site, Autonoma, Buenos Aires, Argentina

Loading trial locations.

About this study

Clinical trials is being held in different countries. The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subjects with community-acquired pneumonia requiring:

  • initial hospitalization or treatment in an emergency room or urgent care setting
  • infection requiring initial treatment with IV antimicrobial

Exclusion criteria

  • Community-acquired pneumonia suitable for outpatient therapy with an oral antimicrobial agent
  • Respiratory tract infections not due to community-acquired bacterial pathogens
  • Infections resistant to ceftriaxone
  • Any condition requiring concomitant systemic corticosteroids
  • History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial

Treatment and study plan

Ceftaroline fosamil for Injection

Drug

2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days

Other names: Experimental

Ceftriaxone

Drug

1 g dose parenteral infused over 30 minutes, every 24 hours for 5 to 7 days

Other names: Active comparator

Placebo

Drug

Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind

Primary outcomes

  1. Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population

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

    Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary

    Failure: Any of the following:

    • Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy
    • Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia
    • Death wherein pneumonia (ie,CABP) was considered causative

    Indeterminate: Inability to determine an outcome

  2. Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population

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

Secondary outcomes

  1. Clinical Response at End of Therapy (EOT)

    Time frame: Last day of study drug administration

  2. Microbiological Success Rate at TOC

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

  3. Overall Clinical and Radiographic Success Rate at TOC

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

  4. Clinical and Microbiological Response by Pathogen at TOC

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

  5. Clinical Relapse at Late Follow Up (LFU) Visit

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

  6. Microbiological Reinfection/Recurrence at LFU

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

  7. Evaluate Safety

    Time frame: first dose, throughout the treatment period, and up to the TOC visit

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 Ceftriaxone in the Treatment of Adult Subjects With Community-Acquired Pneumonia

Acronym: CAP

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Jul 31, 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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