Clinical trial NCT01605864: Use of Ceftaroline in Hospitalized Patients With Community Acquired Pneumonia
Official title: Ceftaroline Fosamil Versus Standard of Care for Community Acquired Bacterial Pneumonia (CABP): Clinical Outcomes Among Hospitalized Adults at a Single United States Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Community Acquired Bacterial Pneumonia
Keywords: pneumonia
community acquired bacterial pneumonia
CAP
CABP
bacterial pneumonia
Lead sponsor: Albany Medical College
Sponsor class: OTHER
Collaborators: name: Albany College of Pharmacy and Health Sciences
name: Forest Laboratories
First posted: 2012-05-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Community-acquired bacterial pneumonia, which is often called CAP, is a bacterial infection in the lungs and is treated with antibiotics. Sometimes people need to be in the hospital to be treated for CAP. Usually, hospitalized persons with CAP are given two antibiotics together. These antibiotics usually include a cephalosporin and a macrolide. The most commonly used cephalosporin at Albany Medical Center Hospital is ceftriaxone. The most commonly used macrolides at Albany Medical Center Hospital are azithromycin and doxycycline.

This research is being done to find out how well a new cephalosporin antibiotic, called ceftaroline, works in combination with a macrolide for the treatment of CAP. Ceftaroline is similar to ceftriaxone. Ceftaroline was recently approved by the FDA to treat pneumonia in hospitalized patients based on two research studies. In one study, ceftaroline was better than ceftriaxone. In the second study, ceftaroline was just as good as ceftriaxone. Ceftaroline was very well tolerated in both clinical studies and it was found to be as safe as ceftriaxone.


Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* met ATS/ISDA criteria rule of CABP
* CABP requiring hospitalization and treatment with a IV antimicrobial
* anticipated hospitalization for \> 48 hours
* received ceftaroline in combination with a macrolide (clarithromycin, or azithromycin) for \> 48 hours within the first 24 hours after presentation to the hospital and must have remained on therapy for at least 48 hours after admission
* Pneumonia Patient Outcomes Research Team (PORT)risk class III or IV

Exclusion Criteria:

* CABP PORT Risk class I, II, III
* CABP requiring admission to an ICU
* CABP suitable for outpatient therapy with an oral microbial agent
* confirmed or suspected respiratory tract infection attributed to a source other than CABP pathogens
* noninfectious case of pulmonary infiltrates or pleural empyema
* infection with a pathogen know to be resistant to ceftaroline or epidemiological/ clinical context suggesting a high likelihood of a resistant pathogen
* previous therapy with another intravenous beta-lactam for CABP for between 24 and 96 hours prior to randomization
* receipt of chronic concomitant systemic steroids \> 40 mg of prednisone equivalent
* significant hepatic disease
* hematologic disease
* Immunological disease
* history of a hypersensitivity reaction to beta-lactams
* pregnant or nursing females

Primary outcomes:
measure: Achieving clinical stability
timeFrame: day 2
measure: Achieving clinical stability
timeFrame: day 3
measure: Achieving clinical stability
timeFrame: day 4
Secondary outcomes:
measure: Achieving clinical stability
timeFrame: day 5
measure: Hospital Readmission
timeFrame: day 30
measure: All-cause mortality
timeFrame: day 30
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
affiliation: Albany Medical College
name: Wayne Triner, DO, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Albany College of Pharmacy and Health Sciences
name: Tom Lodise, PharmD
role: PRINCIPAL_INVESTIGATOR
References: