FOSFOLD - Fosfomycin trometamol compared with another active antibiotic relay therapy for the treatment of acute Escherichia coli pyelonephritis in elderly women: a randomized, multicenter, non-inferiority trial

Condition studied

Women aged 75 years or older presenting with E. coli pyelonephritis

Investigational medicinal product(s)

Every trial of Cefotaxime, Ertapenem, Ceftazidime and Aztreonam across our registers →

Eligibility

Primary endpoint

Temperature <38°C and the absence of urinary infection symptoms between the end of treatment and the evaluation of the primary endpoint on Day 17, except for a value ≥38°C not related to the urine, Absence of resumption of an antibiotic therapy active against the bacteria responsible for acute pyelonephritis following the end of antibiotic treatment

Endpoint detail

- Occurrence, nature, and severity of adverse events related to antibiotics, measured by the National Cancer Institute's Common Terminology Criteria for Adverse Events scale, Geriatric complications: • Occurrence of confusion (definition according to the CAM tool) • Fall(s) • Weight loss: evaluated as a percentage between the admission weight and the discharge weight or at day 17 if the patient is still hospitalized • Appearance of pressure ulcers, Functional autonomy according to the A.D.L. scale at the end of follow-up on day 37, Incidence of infectious and urological complications, evaluated at the end of antibiotic therapy (day 7): • Renal abscess • Need for urinary drainage • Transfer to continuous care or intensive care related to the infection, Cumulative incidence of febrile or non-febrile UTI recurrence (recurrence or reinfection) between day 17 and day 37: • Cystitis: reappearance of urinary functional signs without fever with a positive urine culture • Pyelonephritis (PNA): reappearance of urinary functional signs with fever and a positive urine culture • Reinfection: new infection caused by a different bacterium than the initial episode • Recurrence: new infection caused by the same bacterium as the initial episode, Rate of (re)hospitalization following the management of pyelonephritis (PNA), Number of days of hospitalization post-randomization, Mortality at day 37, Rate of rectal colonization with antibiotic-resistant Enterobacteriaceae (FQ, SMX-TMP, fosfomycin, and third-generation cephalosporins) between day 1 and day 37