Vancomycin Versus Ceftaroline in Patients With Infections Caused by MRSA That Are Susceptible to Ceftaroline
Vancomycin Versus Ceftaroline in Patients With Infections Caused by MRSA That Are Susceptible to Ceftaroline
To compare the time to pathogen eradication, and the relationship to the time to clinical
 improvement, between ceftaroline and case-matched vancomycin treated controls in the
 treatment of adults with serious infections caused by Methicillin-Resistant Staphylococcus
 aureus (MRSA).
Inclusion Criteria:

 1. A positive MRSA culture, resulting from a blood or properly obtained infection site
 sample, with a vancomycin MIC 1.5 - 4.0 mcg/mL and ceftaroline MIC ≤1 mcg/mL.

 2. The patient was treated adequately with ceftaroline or vancomycin.

 3. A medical history, clinical signs and symptoms, and radiological findings consistent
 with infection such as pneumonia, skin and wound, intra-abdominal infection and
 bacteremia associated with one of those infection sites.

 Patients must have had a body temperature >38C [100.4F] or <36.1C [97F] or
 leukocytosis (blood leukocyte count >10,000 cells/mm3) or >10% bands, at baseline. In
 the case of pneumonia, chest radiographic examination that show a new or progressive
 infiltrate, consolidation, cavitation, or pleural effusion. Rales or dullness to
 percussion on physical examination of the chest, new onset of purulent sputum, or
 change in quantity or character of sputum. Wound redness, swelling, and/or purulence
 in the case of ABSSSI

 4. There should be sufficient numbers of follow up cultures of the infection site and/or
 blood to determine whether the infecting pathogen was eradicated, and preferably the
 day on which the eradication occurred.

 Additional inclusion criteria for patients with pneumonia:

 1. Suspected or confirmed acute bacterial pneumonia due to MRSA in one of the following
 subgroups:

 Community-acquired bacterial pneumonia (CABP) i.e. those cases acquired outside the
 hospital and being admitted to the hospital for treatment of their pneumonia;

 or

 Hospital-acquired bacterial pneumonia (HABP), i.e., pneumonia that occurs 72 hours or
 more after admission, which was not incubating at the time of admission;

 or

 Ventilator-associated bacterial pneumonia (VABP), i.e., pneumonia that arises more
 than 48 hours after endotracheal intubation and ventilation;

 or

 Health Care-associated bacterial pneumonia (HCABP), which includes patients admitted
 from a long term care facility.

 2. Pulmonary infiltration consistent with the diagnosis of pneumonia (new or progressive
 infiltrates, consolidation, with or without the presence of pleural effusion)
 documented by chest X-ray or CT within 48 hours prior to enrollment.

 3. Suitable respiratory specimen (sputum/endotracheal specimen or specimen from an
 invasive procedure) for culture and Gram stain, with Gram-positive pathogens as the
 predominant organism. Average of at least 10 Gram-positive organisms per oil-immersion
 field in 10 fields (actual or calculated, 100x objective).

 Additional inclusion criteria for patients with other infection sites:

 1. In all cases of bacteremia linked to a site/source, the isolate species and
 susceptibility should match between blood and primary site. Typical non-pneumonia
 sites of infection will include complicated intra-abdominal (cIAI) and ABSSSI.

 2. In contrast, bacteremic patients with IV catheter as the only source will require that
 the catheter was removed/replaced, and yet the patient remains culture positive for at
 least 24 hr after replacement of the catheter.

 Exclusion Criteria

 1. Age <18 years

 2. Pregnant or lactating women

 3. Life expectancy <3 months from underlying disease

 4. Infection with Mycobacterium tuberculosis

 5. Organism is not available or is not tested locally for MIC to ceftaroline or
 vancomycin

 6. Bacteremia determined to be catheter-related with no definitive evidence of a
 secondary source

 7. Patient is on a prior antibiotic and shows clinical improvement or negative cultures
 before treatment of ceftaroline (or vancomycin for control patients).