A multicenter prospective study for the investigation of the validity of the cutoff values established for the HIRA-TAN system.
Not Applicable
- Conditions
- Pneumonia (acute lower respiratory infection)
- Registration Number
- JPRN-UMIN000001694
- Lead Sponsor
- Saitama Medical University
- Brief Summary
The primary endpoint for the last study (UMIN ID: UMIN000001118) was the proportion of the samples in which S. pneumoniae was judged as a significant pathogen on HIRA-TAN compared to that in which S. pneumoniae was shown to be a causative pathogen on existing test. The proportion was 0.93 (40/43; 95% confidence interval (CI): 0.83<), as a Sensitivity, and a Negative Predictive Value was also 0.93.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
Not provided
Exclusion Criteria
Patients that do not fulfill the inclusion criteria.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Validity of the cutoff value for Haemophilus influenzae and Pseudomonas spp..
- Secondary Outcome Measures
Name Time Method Validity of the cutoff values for Moraxella catarrhalis, Klebsiella pneumoniae, and Stahylococcus aureus. Overall performance of HIRA-TAN system to identify the causative pathogen of pneumonia.