Here is the design of a clinical trial:

Official Title: Double-blinded Multicenter Randomized Controlled Trial Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia

Included conditions:
- Pneumonia, Ventilator-Associated

Study Armgroups:
- {'label': 'Inhaled amikacin', 'type': 'EXPERIMENTAL', 'description': 'Inhaled amikacin at day 4, day 5 and day 6 of invasive mechanical ventilation: 20 mg/kg of ideal body weight, maximum 2 g per day.', 'interventionNames': ['Drug: Inhaled amikacin']}
- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Once a day, inhaled placebo at day 4, day 5 and day 6 of invasive mechanical ventilation.', 'interventionNames': ['Drug: Inhaled placebo']}

Interventions:
- {'type': 'DRUG', 'name': 'Inhaled amikacin', 'description': 'Once a day, inhaled amikacin at day 4, day 5 and day 6 of invasive mechanical ventilation: 20 mg/kg of ideal body weight, maximum 2 g per day.', 'armGroupLabels': ['Inhaled amikacin']}
- {'type': 'DRUG', 'name': 'Inhaled placebo', 'description': 'Once a day, inhaled placebo at day 4, day 5 and day 6 of invasive mechanical ventilation.', 'armGroupLabels': ['Placebo']}

Primary Outcomes:
- {'measure': 'Incidence of a first VAP episode from randomization to day 28', 'timeFrame': 'Patients will be followed from randomization to day 28'}

Please estimate the sample size based on the assumption: 
Power set at 80%, two-tailed type I error at 5%, and consideration of the competing risk of death before extubation or VAP occurrence.
Sample size
        The following hypothesis is based on data of a previous trial of the CRICS-TriggerSEP research network and epidemiological surveillance data39 40:
        
          
            Incidence of first VAP episode of 12% in the control group.
          
          
            Incidence of first VAP episode of 6% in the experimental group.
          
        
        Those hypotheses are conservative in terms of baseline VAP incidence and plan an important relative risk reduction which is deemed necessary to drive clinical practice change towards pre-emptive antibiotic inhalation in case of a positive trial. Indeed, a smaller risk reduction may be considered insufficient by the clinical community to implement large scale pre-emptive antibiotic therapy.
        Sample size calculation took into consideration the competing risk of death occurring before extubation or VAP occurrence.41 Power was set at 80% and two-tailed type I error at a 5%. A total number of 850 patients (425 in each arm) will be included in the trial.