Community-Acquired Bacterial Pneumonia (CABP)
Conditions
Keywords
Community-Acquired Pneumonia, Lung, Adult, Infections
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.
Interventions
IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment)
Sponsors
Forest Laboratories
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed