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Completed

NCT Number: NCT01645735

Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus

The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant Staphylococcus aureus (MRSA).

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Key information

Conditions

Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigational Site, Tbilisi, Georgia

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About this study

A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and safety of Ceftaroline fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects with Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus aureus.

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 All of the following inclusion criteria:
  • Male or female, ≥ 18 years old
  • Presence of CABP requiring hospitalization
  • Presence of CABP meeting the following criteria:

I. confirmed pneumonia (new or progressive pulmonary) II. Acute illness (≤ 7 days' duration) with at least 3 clinical signs or symptoms consistent with a lower respiratory tract infection

MRSA Risk Factors

  • MRSA-positive blood culture or respiratory specimen or a risk factor for MRSA such as a history of colonization with MRSA

Exclusion criteria

  • Subjects must Not meet any of the following exclusion criteria at baseline:
  • History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
  • Suspected or microbiologically-documented infection with a pathogen known to be resistant to any of the study drugs
  • Non-infectious causes of pulmonary infiltrates (eg, pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
  • More than 24 hours of potentially effective systemic antibacterial therapy for CABP within 96 hours before randomization
  • End-stage renal disease [Creatinine Clearance (CrCl) < 15], including hemodialysis
  • Evidence of significant hepatic, hematological, or immunocompromising condition

Treatment and study plan

Ceftaroline fosamil

Drug

Ceftaroline fosamil 600 mg IV over 60 minutes q8h; treatment duration 5 to 14 days

Other names: Teflaro, PPI-0903, TAK-599, TAK599, PPI0903 Teflaro

Ceftriaxone plus vancomycin

Drug

Ceftriaxone 2g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days

Primary outcomes

  1. Clinical Response at Study Day 4 in the Modified Intent-to-Treat (MITT) Population

    Time frame: Study Day 4

    Clinical response was defined as meeting all of the following criteria:

    • Symptom Improvement - Improvement in at least 2 and no worsening of any of the following symptoms compared to baseline:
    • Cough
    • Dyspnea
    • Sputum production
    • Chest pain
    • Clinical Stability (per Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) guidelines; Mandell et al, 2007):
    • Temperature ≤ 37.8°C
    • Heart rate ≤ 100 beats/min
    • Respiratory rate ≤ 24 breaths/min
    • Systolic blood pressure ≥ 90 mmHg
    • Oxygen saturation ≥ 90%
    • Confusion/disorientation absent

  2. Clinical Outcome at Test of Cure (TOC) in the MITT Population

    Time frame: Test of Cure, an average of 3 weeks

    An assessment of clinical outcome was made by the Investigator at TOC. The clinical outcome categories were:

    Cure: Resolution of all acute signs and symptoms of CABP or improvement to such an extent that no further antimicrobial therapy was required

    Failure: Subjects who meet either of the following criteria:

    • Incomplete resolution or worsening of CABP signs and symptoms or development of new CABP signs or symptoms requiring alternative nonstudy antimicrobial therapy
    • Death in which CABP is contributory

    Indeterminate: Study data are not available for evaluation of efficacy for any reason, including:

    • Death in which CABP is clearly noncontributory
    • Lost to follow-up
    • Extenuating circumstances precluding classification as a cure or failure

    A favorable clinical outcome at Test-of Cure (TOC) was clinical cure.

Other outcomes

  1. Microbiological Outcomes by Baseline Pathogen at TOC in the Microbiological Modified Intent-to-Treat (mMITT) Population

    Time frame: Test of Cure, an average of 3 weeks

    An overall microbiological outcome was derived based on the subject's baseline pathogen. As no follow-up specimens were collected at the TOC visit for any subjects, all microbiological outcomes were derived based strictly on clinical outcomes, as either presumed eradication (ie, source specimen was not available to culture and the subject was assessed as clinical cure) , presumed persistence (ie, source specimen was not available to culture and the subject was assessed as a clinical failure), or indeterminate (ie, source specimen was not available to culture and the subject's clinical response was assessed as indeterminate).

  2. Safety Evaluation

    Time frame: Baseline (Day 0) to Day 49

    Adverse events (AEs), serious adverse events (SAEs), deaths, discontinuation due to AEs

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Collaborators

  • AstraZeneca

Registry information

Official study title

A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects With Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus Aureus

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 20, 2012
Registry last updated
Feb 1, 2016

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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