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

Community-Acquired Bacterial Pneumonia (CABP) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01666743
• Other study ID #: CPT-MD-34
• Status: Withdrawn
• Phase: Phase 4
• First received: August 14, 2012
• Last updated: February 7, 2013
• Start date: November 2012
• Est. completion date: March 2014

Study information

• Verified date: February 2013
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 ß-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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community-Acquired Bacterial Pneumonia (CABP)
• Pneumonia
• Pneumonia, Bacterial

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Between 3 and 33-37 days	Yes
Secondary	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	30 days following discharge from the hospital, anticipated between 33 to 37 days.	No

External Links

•   Sponsor Website