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Safety and Efficacy Study of Ceftaroline in Elderly Subjects With Community-Acquired Bacterial Pneumonia

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ClinicalTrials.gov Identifier: NCT01666743
Recruitment Status : Withdrawn (Change in strategy.)
First Posted : August 16, 2012
Last Update Posted : February 11, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the safety and efficacy of ceftaroline fosamil in elderly subjects with community-acquired bacterial pneumonia (CABP) receiving antibiotic therapy in the hospital.

Condition or disease Intervention/treatment Phase
Community-Acquired Bacterial Pneumonia (CABP) Drug: Ceftaroline fosamil Phase 4

Detailed Description:
This is a multicenter study of ceftaroline fosamil in elderly subjects (≥ 65 years of age) with CABP. Adjunctive macrolide therapy is to be used at the Investigator's discretion. A switch to oral treatment may be allowed at the discretion of the Investigator. The total duration of therapy is 5 to 7 days; a minimum of 48 hours of study drug is required.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Study to Describe the Safety and Efficacy of Ceftaroline Fosamil in Elderly Subjects With Community-Acquired Bacterial Pneumonia
Study Start Date : November 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ceftaroline fosamil
IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment)
Drug: Ceftaroline fosamil
IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment)
Other Names:
  • Teflaro®
  • PPI-0903
  • TAK-599
  • TAK599
  • PPI0903


Outcome Measures

Primary Outcome Measures :
  1. Evaluate the safety of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP) [ Time Frame: Between 3 and 33-37 days ]

    Safety evaluations will be conducted and assessments will include:

    • Adverse events including deaths will be evaluated.
    • Laboratory: complete blood count with differential, and chemistry panel.


Secondary Outcome Measures :
  1. Evaluate the efficacy of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP) [ Time Frame: 30 days following discharge from the hospital, anticipated between 33 to 37 days. ]

    Efficacy outcome measures:

    • Time to clinical stability
    • Length of stay
    • Clinical outcome at End-of-Intravenous Study Drug, End-of-Therapy, and Test-of-Cure
    • Mortality
    • 30-day readmission


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female ≥ 65 years of age.
  2. Presence of CABP warranting hospitalization.
  3. Acute illness with ≥ 2 clinical signs or symptoms of lower respiratory tract infection.
  4. Radiographically confirmed pneumonia.

Exclusion Criteria:

  1. History of any hypersensitivity or allergic reaction to any β-lactam or macrolide antibacterial agent.
  2. Confirmed or suspected respiratory tract infection due solely to an atypical bacterial, mycobacterial, viral, or fungal pathogen.
  3. More than 24 hours of potentially effective antibacterial therapy within 96 hours prior to enrollment.
  4. Life expectancy of < 30 days or presence of an order of Do Not Resuscitate (DNR).
  5. Evidence of significant hematologic, hepatic, or immunologic impairment.
More Information

Additional Information:
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01666743     History of Changes
Other Study ID Numbers: CPT-MD-34
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: February 2013

Keywords provided by Forest Laboratories:
Community-Acquired Pneumonia
Lung
Adult
Infections

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents