safo {flowchart}

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)

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