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

This study has been withdrawn prior to enrollment.
(Change in strategy.)
Sponsor:
Information provided by (Responsible Party):
Cerexa, Inc.
ClinicalTrials.gov Identifier:
NCT01666743
First received: August 14, 2012
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Community-Acquired Bacterial Pneumonia (CABP)
 Drug: Ceftaroline fosamil
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by Cerexa, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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:
  • 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. ] [ Designated as safety issue: No ]

    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


Enrollment: 0
Study Start Date: November 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
Sponsor Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Cerexa, Inc.
ClinicalTrials.gov Identifier: NCT01666743     History of Changes
Other Study ID Numbers: CPT-MD-34
Study First Received: August 14, 2012
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Cerexa, Inc.:
Community-Acquired Pneumonia
Lung
Adult
Infections

Additional relevant MeSH terms:
Pneumonia, Bacterial
Pneumonia
Bacterial Infections
 Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 23, 2013