Here is the design of a clinical trial:

Official Title: A Multicentre, Parallel Group Open-label Randomised Controlled Non-Inferiority Phase 3 Trial, of Ceftolozane-tazobactam Versus Meropenem for Definitive Treatment of Bloodstream Infection Due to Extended-Spectrum Beta-Lactamase (ESBL) and AmpC-producing Enterobacterales

Included conditions:
- Bacteremia Caused by Gram-Negative Bacteria

Study Armgroups:
- {'label': 'Ceftolozane-tazobactam', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive ceftolozane-tazobactam 3 grams (comprising ceftolozane 2 grams and tazobactam 1 gram) administered, every 8 hours, three times a day, intravenously over 60 mins', 'interventionNames': ['Drug: Ceftolozane-Tazobactam']}
- {'label': 'Meropenem', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will receive meropenem 1 gram, every 8 hours, three times a day, intravenously over 30 mins.', 'interventionNames': ['Drug: Meropenem']}

Interventions:
- {'type': 'DRUG', 'name': 'Ceftolozane-Tazobactam', 'description': 'Ceftolozane-tazobactam 3 grams (comprising ceftolozane 2 grams and tazobactam 1 gram) administered, every 8 hours, three times a day, intravenously over 60 mins. Dose adjusted for renal function.', 'armGroupLabels': ['Ceftolozane-tazobactam']}
- {'type': 'DRUG', 'name': 'Meropenem', 'description': 'Meropenem 1 gram, every 8 hours, three times a day, intravenously over 30 mins. Dose adjusted for renal function.', 'armGroupLabels': ['Meropenem']}

Primary Outcomes:
- {'measure': 'Mortality rate at 30 days', 'description': 'To compare the 30-day mortality from day of randomisation of each regimen', 'timeFrame': '30 days post randomisation'}

Please estimate the sample size based on the assumption: 
80% power to declare non-inferiority, 5% significance level, and considering a dropout rate to achieve 600 patients contributing to the primary outcome analysis.
Sample size {14}
        The sample size is driven by the maximum achievable power with the constraint of a predefined quantity of ceftolozane-tazobactam to be supplied by MSD. We anticipate that a trial with 600 patients contributing to the primary outcome analysis (corresponding to 630 patients randomised) may be possible. Such a trial would have 80% power to declare non-inferiority with a 5% non-inferiority margin, assuming a 30-day mortality of 5% in both randomised groups. The decision to choose 5% as the expected 30-day mortality reflects the 30-day mortality rate of 4â5% reported by our group in the meropenem arm of the MERINO trial [11]. However, a similar study has assumed a 30-day mortality rate of 12.5% in the meropenem arm [17]. This mortality rate was based on both arms of the MERINO trial and contemporary observational studies [4]. If the control rate is higher than 5% we will have less power to detect non-inferiority (assuming equivalent rates in the two arms). If the control rate is 5%, the non-inferiority margin of 5% may be deemed by some to be too large. As recommended by the CONSORT statement, we will report relative risk ratios as well as absolute risk differences.
        
          Recruitment {15}
          We plan to conduct this trial over a 4-year period. Participants will be recruited from a maximum of 40 sites across 6 countries. Of those participants screened, we anticipate approximately 25% will be enrolled successfully in the trial. This estimate was generated from the MERINO trial.
          The table below highlights the minimum projected monthly and annual recruitment numbers to reach target (630) depending upon the number of sites. It assumes all sites are recruiting simultaneously, however, it is projected that the majority of the sites will be recruiting within a 9-month period, and the early adoptive sites will recruit ahead of the initial target thereby balancing timelines.
          In the event of delayed recruitment milestones, pre-defined contingency measures including, the addition of eligible sites and the introduction of further rapid antibiotic susceptibility testing (e.g. AcceleratePhenoâ¢) will be implemented (Table 4).
Table 4Predicted recruitment per site and timeline# SitesPer monthPer annum113.1157.5101.315.7150.910.5200.77.9250.56.3300.45.2350.44.5400.33.9