Pneumonia whose Pneumonia clinical stratification (PORT score) is IV or V.
Conditions
Interventions
None listed
Sponsors
Nagasaki evaluation organization for clinical interventions
Eiken Chemical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Regardless of inpatient or outpatient. 2) Suspected CAP patient who presents a new typical infiltrative shadow on CXR or CT image taken <48 hr before this study and who shows at least one other typical symptom described below Coughing, or its exacerbation Purulent sputum or its deteriorating. Abnormal finding based on auscultation and percussion Breathing difficulties and/ or Tachypnea Fever with > 37 degree (axilla measurement) Leukocytosis (white blood cell > 10,000/mm3), or stab cell > 15%, or leukocytopenia (white blood cell <4,500/mm3) CRP increasing (in according to an criteria of each study site) Hypoxemia 3) Eligible patient who provides the informed consent signed by himself or his proxy. 4) Patient Pneumonia clinical stratification (PORT score) is IV or V.
Exclusion criteria
Exclusion criteria: 1) Patient for whom clinical follow-up and a clear final diagnosis are judged to be difficult. 2) Patient who is obviously suspected to be TB or aspiration pneumonia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate a clinical performance of Legi-LAMP for a pneumoniae diagnosis in comparison of conventional IVDs and nucleic acid detection methodology. 1) Comparison of Legi-LAMP and Serological test Analysis of a positive agreement rate (sensitivity), a negative agreement rate (specificity) and an overall agreement rate between Legi-LAMP and serological test. 2) Comparison of Legi-LAMP and Urinary antigen test Analysis of a positive agreement rate (sensitivity), a negative agreement rate (specificity) and an overall agreement rate between Legi-LAMP and Urinary antigen test. 3) Comparison of Legi-LAMP and PCR Analysis of a positive agreement rate (sensitivity), a negative agreement rate (specificity) and an overall agreement rate between Legi-LAMP and PCR | — |
Countries
Japan
Contacts
Public ContactTaiga Miyazaki
Nagasaki evaluation organization for clinical interventions office
Outcome results
None listed