urinary sepsis
Conditions
Interventions
Trade Name: MONUROL 3 g
Pharmaceutical Form: Granules for oral solution
INN or Proposed INN: FOSFOMYCIN
CAS Number: 23155-02-4
Concentration unit: GBq/g gigabecquerel/gram
Concentration type: equal
Co
Sponsors
Fundación para Formación e Investigación Sanitaria
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: ? Age over 18 years. ? A patient who attends hospital outpatient biopsy protática by PSA over 4 ng / ml or suspicious digital rectal tumor. ? Subjects who have given written informed consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: ? History (confirmed or suspected) allergy to any of the drugs included in the study. ? History (confirmed or suspected) of intolerance to any of the drugs included in the study. ? Presence of urinary tract infection confirmed by urine culture or urinalysis. ? Clinical findings suggestive of infection (any origin). ? Antibiotic therapy in the last 4 weeks. ? Patient carrier catheter.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the incidence of symptomatic or asymptomatic bacteriuria after transrectal ultrasound guided prostate by using a single dose of fosfomycin 3 g one hour before the biopsy compared to that observed with the use of ciprofloxacin 500 mg 1 hour before the biopsy.;Primary end point(s): ? Bacteriuria. Appearance in the urine culture of a significant number of bacteria (> 105 cfu / ml).;Timepoint(s) of evaluation of this end point: -Dia 25 post-biopsia prostatica;Secondary Objective: To compare the incidence of genitourinary infection associated with fever (> 38 ° C), incidence of sepsis and other complications after transrectal prostate biopsy under ultrasound guidance by using a single dose of fosfomycin 3 g one hour before the biopsy compared to that observed with the use of ciprofloxacin 500 mg 1 hour before the biopsy. ? Description of the pathogen and resistance observed in the present positive urine cultures was performed on both treatment groups. ? Description of pathogens in positive blood cultures of patients who have undergone a sepsis secondary to biospsia. ? To analyze the association between bacteriuria or urinary tract infection after prostate biopsy and the following variables: age, prostate volume, biopsy results (positive or negative for malignancy) and number of prostate biopsies prior to today. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Urinary tract infection ? Genitourinary infections associated with fever (> 38 ° C) ? Sepsis. ? Pathogens present in urine and their sensitivity to antibiotics ? Bacteremia ? Clinical and demographic variables;Timepoint(s) of evaluation of this end point: These variables are meseaure when the patients develope the nexts tipe infection: ? Urinary tract infection ? Genitourinary infections associated with fever (> 38 ° C) ? Sepsis. ? Pathogens present in urine and their sensitivity to antibiotics ? Bacteremia This Varibles is measure in day 0: ? Clinical and demographic variables | — |
Countries
Spain
Contacts
Public ContactJavier Júdez Gutiérrez
Fundación para Formación e Investigación Sanitaria
Outcome results
None listed