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

February 7, 2013 updated by: Forest Laboratories

A Multicenter Study to Describe the Safety and Efficacy of Ceftaroline Fosamil in Elderly Subjects With Community-Acquired Bacterial Pneumonia

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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:
  • PPI-0903
  • TAK-599
  • TAK599
  • PPI0903
  • Teflaro®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Between 3 and 33-37 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days following discharge from the hospital, anticipated between 33 to 37 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ANTICIPATED)

September 1, 2013

Study Completion (ANTICIPATED)

March 1, 2014

Study Registration Dates

First Submitted

August 14, 2012

First Submitted That Met QC Criteria

August 14, 2012

First Posted (ESTIMATE)

August 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPT-MD-34

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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