PASSReviewer 1· 90% conf
The trial design is rigorous with clear randomization, sample size calculation, and pre-specified analysis populations, though blinding was not possible.
Evidence
direct quote[Methods, Randomisation and blinding]
“Patients were randomised following consent by the trial team at participating sites with a 1:1 allocation ratio, using a computer-generated randomisation sequence with random block sizes generated from a master list by the trial statistician and stratified by health facility.”direct quote[Methods, Sample size]
“Assuming 90% of individuals receiving an aminoglycoside plus ciprofloxacin would meet the primary endpoint of therapeutic response on D11 (10% treatment failure), 190 confirmed or probable bubonic plague cases (95 per group) were required to have 90% power to demonstrate the non-inferiority of a ciprofloxacin monotherapy, with a 15% non-inferiority margin and a one-sided alpha of 2.5% and allowing for 10% loss to follow-up.”direct quote[Methods, Randomisation and blinding]
“Blinding of patients and the trial team to treatment allocation was not possible due to the different treatment administration routes.”PASSReviewer 2· 95% conf
The trial design is rigorous with clear randomisation, sample size calculation, and pre-specified analysis populations.
Evidence
direct quote[Methods, Randomisation and blinding]
“Patients were randomised following consent by the trial team at participating sites with a 1:1 allocation ratio, using a computer-generated randomisation sequence with random block sizes generated from a master list by the trial statistician and stratified by health facility.”direct quote[Methods, Sample size]
“Assuming 90% of individuals receiving an aminoglycoside plus ciprofloxacin would meet the primary endpoint of therapeutic response on D11 (10% treatment failure), 190 confirmed or probable bubonic plague cases (95 per group) were required to have 90% power to demonstrate the non-inferiority of a ciprofloxacin monotherapy, with a 15% non-inferiority margin and a one-sided alpha of 2.5% and allowing for 10% loss to follow-up.”direct quote[Methods, Randomisation and blinding]
“Blinding of patients and the trial team to treatment allocation was not possible due to the different treatment administration routes.”