Results
REGRESSION, EVENTS, SECONDARY
Among the 143 patients included in the modified intention-to-treat population of the FOREST trial, 108 (75.5%) were switched to oral drugs and 35 were not (Figure In order to provide information about the generalizabilty of the results, we compared the 108 patients who were switched to oral drugs with the 35 who were not; the data are shown in Table For the comparison of oral drugs, we included 61 patients switched to oral fosfomycin trometamol (the 60 randomized to IV fosfomycin plus 1 patient randomized to meropenem who was switched to oral fosfomycin by mistake) and 47 switched to other drugs (28 to cefuroxime axetil, 7 to amoxicillin/clavulanic acid, 7 to trimethoprim/sulfamethoxazole, and 5 to ciprofloxacin).The features of patients stepped-down to oral drugs are shown in Table The outcomes are shown in Table Analysis of the primary endpoint (clinical and microbiological cure) and secondary endpointsAll endpoints were evaluated using ITT criteria (i.e. lack of assessment was considered as not reaching clinical cure or microbiological eradication), except for relapses and reinfections, for which only detected events were considered. Data are number of patients with the endpoint/total treated (percentage). TOC, test of cure.Reasons for not reaching clinical and microbiological cure: lack of urine sample for microbiological assessment, 2; clinical assessment at TOC missing, 2; microbiological failure, 9; clinical failure, 3 (these 3 also had a microbiological failure).Reasons for not reaching clinical and microbiological cure: clinical assessment at TOC missing, 1; microbiological failure, 5; clinical failure, 3.The estimation of the association of fosfomycin trometamol with clinical and microbiological cure was adjusted for age, gender, Charlson index, invasive procedure of the urinary tract and ceftriaxone susceptibility of the isolate in a regression model; the adjusted ORs for CMC, clinical cure and microbiological cure were 1.11 (95% CI: 0.42–3.29, Subgroup analyses for clinical and microbiological cure using ITT criteriaData are number of patients with the endpoint/total treated (percentage).
Among patients treated with fosfomycin trometamol, we explored whether exposure to some key variables was associated with a different risk of CMC. Regarding sex, CMC with fosfomycin was 77.4% (24/31) in men and 80.0% (24/30) in women [relative risk (RR), 0.96; 95% CI: 0.74–1.25; Outcomes of patients treated with fosfomycin trometamol as step-down according to the MIC of the Isolates unavailable for susceptibility testing at central laboratory.AEs were reported for 17 patients receiving oral fosfomycin and nine other oral drugs (27.8% versus 19.1%, 