Clinical response was defined as meeting all of the following criteria:

• Symptom Improvement - Improvement in at least 2 and no worsening of any of the following symptoms compared to baseline:

  • Cough
  • Dyspnea
  • Sputum production
  • Chest pain

• Clinical Stability (per Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) guidelines; Mandell et al, 2007):

  • Temperature ≤ 37.8°C
  • Heart rate ≤ 100 beats/min
  • Respiratory rate ≤ 24 breaths/min
  • Systolic blood pressure ≥ 90 mmHg
  • Oxygen saturation ≥ 90%
  • Confusion/disorientation absent

MITT Population: all randomized subjects who receive any amount of IV study drug and who have a confirmed diagnosis of Community-Acquired Bacterial Pneumonia (CABP) with risk factors for Methicillin-Resistant Staphylococcus aureus (MRSA) (excluding those that have a sole atypical pathogen)

An assessment of clinical outcome was made by the Investigator at TOC. The clinical outcome categories were:

Cure: Resolution of all acute signs and symptoms of CABP or improvement to such an extent that no further antimicrobial therapy was required

Failure: Subjects who meet either of the following criteria:

• Incomplete resolution or worsening of CABP signs and symptoms or development of new CABP signs or symptoms requiring alternative nonstudy antimicrobial therapy
• Death in which CABP is contributory

Indeterminate: Study data are not available for evaluation of efficacy for any reason, including:

• Death in which CABP is clearly noncontributory
• Lost to follow-up
• Extenuating circumstances precluding classification as a cure or failure

A favorable clinical outcome at Test-of Cure (TOC) was clinical cure.

MITT Population: all randomized subjects who receive any amount of IV study drug and who have a confirmed diagnosis of CABP with risk factors for MRSA (excluding those that have a sole atypical pathogen)

An overall microbiological outcome was derived based on the subject's baseline pathogen. As no follow-up specimens were collected at the TOC visit for any subjects, all microbiological outcomes were derived based strictly on clinical outcomes, as either presumed eradication (ie, source specimen was not available to culture and the subject was assessed as clinical cure) , presumed persistence (ie, source specimen was not available to culture and the subject was assessed as a clinical failure), or indeterminate (ie, source specimen was not available to culture and the subject's clinical response was assessed as indeterminate).

mMITT Population: a subset of the MITT Population, including subjects for whom at least 1 typical bacterial pathogen has been identified from an adequate microbiological specimen at baseline

Adverse events (AEs), serious adverse events (SAEs), deaths, discontinuation due to AEs

Safety Population: all randomized subjects who received any amount of IV study drug