Table 3. Protocol for the prospective observatory study.

Study design	A multi-institutional study. Sputum was collected from all outpatients and inpatients (≥18 years of age) who developed pneumonia.
Study period and sample size#	Between April 10, 2008 and April 9, 2009. The study will be terminated before April 9, 2009, when the total number of patients reaches 300, or when the number of patients with pneumonia in which S. pneumoniae is the likely causative pathogen reaches 40.
Eligibility criteria	All patients who provided sputum classified as M2, P1, P2 or P3 by the criteria of Miller and Jones [10]. Sputum is isolated at the earliest convenience, at least within 48 h, after the diagnosis of newly developed pneumonia is established. Sputum is divided into 2 samples; one is submitted for a bacteriological test including Gram staining and culture, and the other is submitted for the HIRA-TAN test. The samples are also submitted for urine antigen test for S. pneumoniae.
Primary endpoint	The proportion of samples in which S. pneumoniae was detected with a ΔCtpathogen ≥ cutoff to those in which S. pneumoniae was shown to be a likely causative pathogen.
Secondary endpoints	The proportion of the samples in which H. influenzae, M. catarrhalis, or Pseudomonas spp. was detected with a ΔCtpathogen ≥ cutoff to those in which each was shown to be a likely causative pathogen.

# The number was determined so that the primary endpoint is evaluated at a resolution of 0.1.