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

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ClinicalTrials.gov Identifier: NCT01645735
Recruitment Status : Completed
First Posted : July 20, 2012
Results First Posted : February 1, 2016
Last Update Posted : February 1, 2016
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Infections Drug: Ceftaroline fosamil Drug: Ceftriaxone plus vancomycin Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRSA Pneumonia

Arm Intervention/treatment
Experimental: Ceftaroline
Ceftaroline fosamil 600 mg Intravenous (IV) administration over 60 minutes, every 8 hours (q8h); dosing to be adjusted for renal function; treatment duration 5 to 14 days
Drug: Ceftaroline fosamil
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

Active Comparator: Ceftriaxone plus vancomycin
Ceftriaxone 2 g IV over 30 minutes once per day (q24h) plus vancomycin 15 mg/kg IV every 12 hours (q12h) initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days
Drug: Ceftriaxone plus vancomycin
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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects are required to meet All of the following inclusion criteria:

    1. Male or female, ≥ 18 years old
    2. Presence of CABP requiring hospitalization
    3. 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:

    1. History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
    2. Suspected or microbiologically-documented infection with a pathogen known to be resistant to any of the study drugs
    3. Non-infectious causes of pulmonary infiltrates (eg, pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
    4. More than 24 hours of potentially effective systemic antibacterial therapy for CABP within 96 hours before randomization
    5. End-stage renal disease [Creatinine Clearance (CrCl) < 15], including hemodialysis
    6. Evidence of significant hepatic, hematological, or immunocompromising condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01645735


  Show 31 Study Locations
Sponsors and Collaborators
Forest Laboratories
AstraZeneca
Investigators
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Study Director: Medical Monitor Forest Laboratories Inc, an affiliate of Allergan plc

Additional Information:
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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01645735     History of Changes
Other Study ID Numbers: P903-25
First Posted: July 20, 2012    Key Record Dates
Results First Posted: February 1, 2016
Last Update Posted: February 1, 2016
Last Verified: December 2015

Keywords provided by Forest Laboratories:
Infections
Teflaro
cephalosporin
Ceftaroline
antibiotics
pneumonia

Additional relevant MeSH terms:
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Infection
Pneumonia
Staphylococcal Infections
Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Ceftriaxone
Methicillin
Ceftaroline fosamil
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents