safo: Random generated dataset from the SAFO study

Description

This dataset is a random generated dataset to reproduce the numbers needed to generate the flowchart of the SAFO study. SAFO is an open-label, multicenter, phase III–IV superiority randomized clinical trial to assess whether cloxacillin plus fosfomycin administered for the initial 7-days of therapy achieves better treatment success than cloxacillin alone in hospitalized patients with MSSA bacteremia.

Usage

data(safo)

Arguments

Format

A data frame with 925 rows and 21 columns

id:: Identifier of each patient. This information does not match the real data.
inclusion_crit:: The patient not met the inclusion criteria?
exclusion_crit:: The patient met the exclusion criteria?
chronic_heart_failure:: Exc1: Chronic heart failure?
expected_death_24h:: Exc2: Clinical status with expected death in <24h?
polymicrobial_bacteremia:: Exc3: Polymicrobial bacteremia?
conditions_affect_adhrence:: Exc4: Conditions expected to affect adhrence to the protocol?
susp_prosthetic_valve_endocard:: Exc5: Suspicion of prosthetic valve endocarditis?
severe_liver_cirrhosis:: Exc6: Severe liver cirrhosis?
acute_sars_cov2:: Exc7: Acute SARS-CoV-2 infection?
blactam_fosfomycin_hypersens:: Exc8: Beta-lactam or fosfomycin hypersensitivity?
other_clinical_trial:: Exc9: Participation in another clinical trial?
pregnancy_or_breastfeeding:: Exc10: Pregnancy or breastfeeding?
previous_participation:: Exc11: Previous participation in the SAFO trial?
myasthenia_gravis:: Exc12: Myasthenia gravis?
decline_part:: The patient declined to participate?
group:: Randomized treatment received: cloxacilin alone / cloxacilin plus fosfomycin
itt:: The patient belongs to the intention to treat (ITT) group?
reason_itt:: Reason for exclusion from the ITT group.
pp:: The patient belongs to the per protocol (PP) group?
reason_pp:: Reason for exclusion from the PP group.

References

Grillo, S., Pujol, M., Miró, J.M. et al. Cloxacillin plus fosfomycin versus cloxacillin alone for methicillin-susceptible Staphylococcus aureus bacteremia: a randomized trial. Nat Med 29, 2518–2525 (2023). https://doi.org/10.1038/s41591-023-02569-0