Here is the design of a clinical trial:

Official Title: A Randomized Clinical Trial of Early Empiric Anti-Mycobacterium Tuberculosis Therapy for Sepsis in Sub-Saharan Africa

Included conditions:
- Tuberculosis
- HIV I Infection
- Sepsis

Study Armgroups:
- {'label': 'Diagnosis dependent / conventional dose anti-TB therapy', 'type': 'NO_INTERVENTION', 'description': 'Standard care per admitting team including ceftriaxone x 7 days\n\nIf subsequent TB test positive, then WHO recommended weight-based anti-TB therapy x 28 days'}
- {'label': 'Immediate anti-TB therapy/conventional dose anti-TB therapy', 'type': 'EXPERIMENTAL', 'description': 'Standard care per admitting team including ceftriaxone x 7 days plus immediate empiric WHO recommended weight-based dose anti-TB therapy x 28 days', 'interventionNames': ['Other: Immediate anti-TB therapy']}
- {'label': 'Diagnosis dependent/sepsis specific dose anti-TB therapy', 'type': 'EXPERIMENTAL', 'description': 'Standard care per admitting team including ceftriaxone x 7 days\n\nIf subsequent TB test positive, then sepsis specific dose anti-TB therapy x 28 days', 'interventionNames': ['Other: Sepsis-specific dose anti-TB therapy']}
- {'label': 'Immediate anti-TB therapy/sepsis specific dose anti-TB therapy', 'type': 'EXPERIMENTAL', 'description': 'Standard care per admitting team including ceftriaxone x 7 days plus immediate empiric sepsis specific dose anti-TB therapy x 28 days', 'interventionNames': ['Other: Immediate anti-TB therapy', 'Other: Sepsis-specific dose anti-TB therapy']}

Interventions:
- {'type': 'OTHER', 'name': 'Immediate anti-TB therapy', 'description': 'Study participants will receive immediate empiric anti-TB therapy', 'armGroupLabels': ['Immediate anti-TB therapy/conventional dose anti-TB therapy', 'Immediate anti-TB therapy/sepsis specific dose anti-TB therapy']}
- {'type': 'OTHER', 'name': 'Sepsis-specific dose anti-TB therapy', 'description': 'Study participants will receive conventional WHO weight-based dose anti-TB therapy', 'armGroupLabels': ['Diagnosis dependent/sepsis specific dose anti-TB therapy', 'Immediate anti-TB therapy/sepsis specific dose anti-TB therapy']}

Primary Outcomes:
- {'measure': '28-day mortality', 'description': 'number of participants with mortality', 'timeFrame': '28 days from enrollment'}

Please estimate the sample size based on the assumption: 
The sample size was calculated to give 80% power, with a two-sided significance level of 5%, allowing for a 20% loss to follow-up.
Sample size calculation
        Sample size calculations indicate that enrolling 109 participants per group (a total of 436 participants) yields sufficient power to meet the primary objectives of the trial, to examine the main effects of the timing of anti-TB therapy and the use of sepsis-specific dosing on 28-day mortality. To reach this goal, each of two regional sites in Moshi, Tanzania and Mbarara, Uganda will enrol 218 participants over a 3-year period, a requirement of 72â73 participants per country per year. This calculation allows for 20% of participants to be discharged (alive) prior to day 28. Kaplan-Meier curves will be used to estimate the survival distribution for each of the four groups, estimating and comparing 28-day mortality based on the complementary log-log transformation.23
        The sample size was calculated to give 80% power, with a two-sided significance level of 5%, for testing each of the main effects of timing and dose on 28-day mortality, assuming a 28-day mortality of 45% in the diagnosis-dependent timing/conventional dose group (upper left cell âaâ in figure 2), 32% in each of the diagnosis-dependent timing/sepsis-specific dosing and immediate timing/conventional dose groups (off-diagonal cells âbâ and âcâ in the figure 2), and 19% in the immediate timing, sepsis-specific dose group (lower right cell âdâ in the figure 2). The calculations allow for a 20% loss to follow-up. An interaction plot for these assumed proportions is shown in figure 4.
        
          Figure 4
          
            Interaction plot of estimated effects of immediate and sepsis-specific dosing strategies in the ATLAS trial. ATLAS, A randomised clinical TriaL of early empiric Anti-Mycobacterium tuberculosis therapy for Sepsis in sub-Saharan Africa.