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

Phase 4

Withdrawn

• Conditions: Community-Acquired Bacterial Pneumonia (CABP)
• Interventions: Drug: Ceftaroline fosamil

• Registration Number: NCT01666743
• Lead Sponsor: Forest Laboratories

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.

Study Timeline

• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-16
• Study Start: 2012-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-11
• Primary Completion: 2013-09
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

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