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

Primary Purpose

Community-Acquired Bacterial Pneumonia (CABP)

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Ceftaroline fosamil

About this trial

This is an interventional treatment trial for Community-Acquired Bacterial Pneumonia (CABP) focused on measuring Community-Acquired Pneumonia, Lung, Adult, Infections

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ceftaroline fosamil

Arm Description

IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment)

Outcomes

Primary Outcome Measures

Evaluate the safety of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)

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)

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

Full Information

NCT ID

NCT01666743

First Posted

August 14, 2012

Last Updated

February 7, 2013

Sponsor

Forest Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT01666743

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Withdrawn

Why Stopped

Change in strategy.

Study Start Date

November 2012 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Forest Laboratories

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Community-Acquired Bacterial Pneumonia (CABP)

Keywords

Community-Acquired Pneumonia, Lung, Adult, Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ceftaroline fosamil

Arm Type

Experimental

Arm Description

IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment)

Intervention Type

Drug

Intervention Name(s)

Ceftaroline fosamil

Other Intervention Name(s)

Teflaro®, PPI-0903, TAK-599, TAK599, PPI0903

Intervention Description

IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment)

Primary Outcome Measure Information:

Title

Evaluate the safety of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)

Description

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.

Time Frame

Between 3 and 33-37 days

Secondary Outcome Measure Information:

Title

Evaluate the efficacy of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)

Description

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

Time Frame

30 days following discharge from the hospital, anticipated between 33 to 37 days.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female ≥ 65 years of age. Presence of CABP warranting hospitalization. Acute illness with ≥ 2 clinical signs or symptoms of lower respiratory tract infection. Radiographically confirmed pneumonia. Exclusion Criteria: History of any hypersensitivity or allergic reaction to any β-lactam or macrolide antibacterial agent. Confirmed or suspected respiratory tract infection due solely to an atypical bacterial, mycobacterial, viral, or fungal pathogen. More than 24 hours of potentially effective antibacterial therapy within 96 hours prior to enrollment. Life expectancy of < 30 days or presence of an order of Do Not Resuscitate (DNR). Evidence of significant hematologic, hepatic, or immunologic impairment.

12. IPD Sharing Statement

Links:

URL

http://www.cerexa.com

Description

Sponsor Website

Learn more about this trial

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

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