title: [Randomized comparative study for the assessment of a new therapeutic schedule of fosfomycin trometamol in postmenopausal women with uncomplicated lower urinary tract infection].
abstract: OBJECTIVE
  To compare two therapeutic regimes in terms of bacterial eradication of post-menopausal with uncomplicated acute cystitis who complete antibiotic treatment.
  
  
  METHODS
  A multicenter, randomized, prospective and controlled study between two short antibiotic regimes: fosfomycin trometamol (FMT) 3g, 2 doses separated by 72hours and ciprofloxacin 250mg every 12hours for 3 days. A total of 118 post-menopausal women were enrolled in the study. They underwent an initial urine culture to know the responsible microorganism and susceptibility to treatment. This was repeated 5-7 days and 4 weeks after the treatment to evaluate bacterial eradication. Clinical symptoms and treatment safety were also evaluated.
  
  
  RESULTS
  There were microbiological data at the onset of the treatment in 82 women (69.49%). Of these, 27 did not have positive culture at the first visit (30.51%), 76 (64.41%) fulfilled all the protocol requirements and adverse effects from the treatment were collected in 113 (95.76%) of the patients enrolled in the study. The germs isolated most frequently were Escherichia coli (E. coli) (76.83%), Klebsiella pneumoniae (K. pneumoniae) (7.32%), Proteus mirabilis (P. mirabilis) (4.89%) and Enterococo sp. (3.66%). In terms of efficacy, no differences were detected in the proportion of patients who achieved bacterial eradication between the two study arms: 62.16% of the patients who received FMT and 58.97% of those treated with ciprofloxacin (chi-square, p=0.78). The proportion of patients who achieved clinical cure was also similar (86.49% for FMT and 82.05% for ciprofloxacin; square, p=0.59). These results indicate similar efficacy of both antibiotics in the treatment of uncomplicated lower tract urinary infection in post-menopausal women. In regards to safety data, the proportion of global adverse effects associated to the treatments was 3.45% for FMT and 9.09% for ciprofloxacin. Treatment compliance was 100% for FMT and 83.64% for ciprofloxacin.
  
  
  CONCLUSIONS
  The FMT administered at a dose of 3g every 72hours (2 total doses) and ciprofloxacin at a dose of 250mg every 12hours during 3 days (6 total doses) have a comparable efficacy profile in lower tract urinary infection in post-menopausal women who adequately comply with the treatment, also having comparable safety. The FMT has a better antimicrobial susceptibility profile and better rate of treatment compliance.
authors.affiliation: Servicio de Urología, Fundación Puigvert, Barcelona, España. jpalou@fundacio-puigvert.es
authors.forename: J
authors.initials: J
authors.lastname: Palou
authors.forename: J C
authors.initials: JC
authors.lastname: Angulo
authors.forename: F
authors.initials: F
authors.lastname: Ramón de Fata
authors.forename: A
authors.initials: A
authors.lastname: García-Tello
authors.forename: C
authors.initials: C
authors.lastname: González-Enguita
authors.forename: A
authors.initials: A
authors.lastname: Boada
authors.forename: M
authors.initials: M
authors.lastname: Sanz
mesh_terms: D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001424:Bacterial Infections / Q000188:drug therapy*; D002939:Ciprofloxacin / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D005260:Female; D005578:Fosfomycin / Q000008:administration & dosage*; D006801:Humans; D017698:Postmenopause; D011446:Prospective Studies; D016037:Single-Blind Method; D014552:Urinary Tract Infections / Q000188:drug therapy*
chemical_list: D000900:Anti-Bacterial Agents; D005578:Fosfomycin; D002939:Ciprofloxacin