Table 4 Study endpoints
Primary safety endpoint | |
Proportion of patients with clinical failure by day 28, defined as: death from any cause, or secondary ICU admission for any cause, or secondary admission to hospital (excluding elective admission), or hospital re-admission after index hospital discharge (excluding elective admission), or local complications due to the LRTI (empyema, lung abscess) | |
Primary efficacy endpoint | |
Proportion of patients prescribed an antibiotic by day 28. | |
Secondary endpoints | |
Number of points on the CAP symptom questionnaire as a surrogate marker of quality of life on days 7, 28, and 90 in each study group. | |
Duration of ED stay in each study group. | |
Rate and duration of hospitalization in each study group | |
Proportion of patients prescribed an antibiotic for a new respiratory infection in each study group between days 28 and 90. | |
Proportion of patients with antibiotic-related side effects and C. difficile infections in each study group. | |
Identification of barriers and facilitators to the implementation of the algorithm with patients and ED physicians involved in the study. | |
Quality-adjusted life years (QALYs), derived from responses to the EQ-5D questionnaire, in each group | |
Measurement of the incremental cost-effectiveness ratio (ICER) of the intervention as compared to usual care. | |
Advanced automatic LUS image analysis method using machine learning to assist in LUS diagnosis and risk stratification. | |
Proportion of physician reaching proficiency in LUS image/video acquisition and interpretation after the training module. | |
Sensitivity, specificity, and area under the ROC of physician “gestalt” and Van Vugt prediction score for CAP diagnosis. | |
Exploratory endpoints | |
Proportion of LRTIs patients with a documented bacterial, viral, and mixed infection. | |
Nasopharyngeal microbiome in adult Swiss patients with LRTIs. | |
Urinary metabolite changes during antibiotic treatment. | |
Presence and expression levels of new generation host biomarkers and transcriptome signature according to etiology and severity of the LRTI |