Here is the design of a clinical trial:

Official Title: Optimization of Sepsis Therapy Based on Patient-specific Digital Precision Diagnostics

Included conditions:
- Sepsis
- Septic Shock

Study Armgroups:
- {'label': '1', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard diagnostics', 'interventionNames': ['Diagnostic Test: Standard diagnostics']}
- {'label': '2', 'type': 'EXPERIMENTAL', 'description': 'Standard diagnostics + NGS', 'interventionNames': ['Diagnostic Test: Next Generation Sequencing (NGS)']}

Interventions:
- {'type': 'DIAGNOSTIC_TEST', 'name': 'Standard diagnostics', 'description': 'Standard diagnostics (Microbial diagnostics by means of standard culture methods + optional consultation of experts in the field of infectious diseases) within the first 72 h after diagnosis of sepsis / septic shock', 'armGroupLabels': ['1']}
- {'type': 'DIAGNOSTIC_TEST', 'name': 'Next Generation Sequencing (NGS)', 'description': 'Standard diagnostics + NGS (Microbial diagnostics using standard culture methods + Next Generation Sequencing + optional consultation of experts in the field of infectious diseases) within the first 72 h after diagnosis of sepsis / septic shock', 'armGroupLabels': ['2']}

Primary Outcomes:
- {'measure': 'Desirability of Outcome Ranking / Response Adjusted for Duration of Antibiotic Risk-Score', 'description': 'DOOR/RADAR-score \\[points\\], (min. 1, max. 5), a lower score indicates a better outcome', 'timeFrame': '28 days'}

Please estimate the sample size based on the assumption: 
A power of 90% with a relative effect of p = 0.6 and a drop-out rate of 12.5%.
Sample size calculation
        For sample size calculation, a sophisticated secondary outcome analysis of the following four large sepsis studies of the SepNet Study Group (VISEP [15], MAXSEP [16], HYPRESS [17], and SISPCT [18]) was performed, in which the above described OCO-groups were represented as follows: OCO 1: 33%, OCO 2: 3%, OCO 3: 22%, OCO 4: 14%, and OCO 5: 28%. It is assumed that the anti-infective treatment period in OCO 1 and OCO 2 is 7âdays in average, whereas it is prolonged up to 15âdays (with a standard deviation of 10âdays) in average in OCO 3 and OCO 4. Based on the assumption that the OCO group can be improved by at least 2 stages in 42% of IG patients in parallel to a shortening of the anti-infective treatment by 2âdays, this would result in a power of 90% with 180 patients in each of the two study groups (CG, IG), provided that an IG patient has a lower DOOR/RADAR score as compared to a CG patient with a relative effect of p = 0.6. Including an additional drop-out rate of 12.5% (and considering these patients as OCO 5) would finally result in an overall sample size of 410 patients (CG: n = 205/IG: n = 205).