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Completed

NCT Number: NCT00621504

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

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia

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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, Buenos Aires, C.a.b.a., Argentina

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About this study

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia. Clinical trials for this study is held in many countries

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subjects are required to meet the following inclusion criteria:

  • Community-acquired pneumonia
  • initial hospitalization, or treatment in an emergency room or urgent care setting
  • infection would require initial treatment with IV antimicrobials.

Exclusion criteria

Subjects must NOT meet any of the following exclusion criteria:

  • CAP suitable for outpatient therapy with an oral antimicrobial agent
  • respiratory tract infections not due to community-acquired bacterial
  • Non-infectious causes of pulmonary infiltrates
  • Pleural empyema
  • Infection with an atypical organism
  • History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial
  • History of any hypersensitivity or allergic reaction to clarithromycin or any macrolide/ ketolide

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

IV Ceftriaxone

Drug

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

Other names: Ceftriaxone

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

Clarithromycin

Drug

In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.

Primary outcomes

  1. Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations

    Time frame: 8 to 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 to That for Ceftriaxone at Test-of-Cure (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 Test of Cure (TOC)

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

  3. Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC)

    Time frame: 8-15 days after last day 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)

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

  6. Microbiological Re-infection/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, With Adjunctive Clarithromycin, in the Treatment of Adult Subjects With Community-Acquired Pneumonia

Acronym: CAP

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Feb 22, 2008
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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