Antibiotic Prophylaxis Clinical Trial
Official title:
Effectiveness of Three Different Times of Starting Antibiotic Prophylaxis in Patients With Asymptomatic Bacteriuria Scheduled for Urological Surgery. A Randomized Multicentric Clinical Trial
Asymptomatic bacteriuria (AB) is the isolation of a bacterium in a sample of urine
appropriately collected from a person who does not have signs or symptoms of urinary
infection. It is common in diabetic women, in pregnant women, in men over 60 years and in
patients with spinal cord injury.
There is clinical evidence that AB should be treated in patients who will be operated on with
urologic surgery because of the risk of presenting infectious complications; however, the
timing of initiating antibiotic therapy has not been established, even in some studies the
prophylaxis has been considered from one to seven days prior to the procedure, without
determining the differences in the outcome for each one of the interventions and causing an
undue and risky use of antibiotics.
A randomized, parallel-design, single-masked clinical trial will be performed to compare and
analysis the bloodstream infections, surgical site infections, readmissions and hospital stay
in three intervention groups, 1) those receiving antibiotics during the previous 5 days to
the procedure; 2) 3 days prior to the procedure; and 3) those who receive only a single dose
of antibiotic on the day of the procedure.
The main expected result is to identify the timing of initiation of antibiotic prophylaxis in
urological procedures in patients with asymptomatic bacteriuria, with the purpose of
diminishing the bloodstream and of the surgical site infections. If it is scientifically
demonstrated that those patients who receive a single dose of antibiotic on the same day of
the procedure, have the same safety and effectiveness compared to the other two groups, would
reduce hospital stay, surgical waiting time and indiscriminate use of antibiotics that
generate multidrug-resistant microorganisms, thus generating an impact on Public Health and
on the quality of care.
n/a
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