An interventional study of Prophylactic antibiotic during five days previous to the procedure and Prophylactic antibiotic during three days previous to the procedure in Asymptomatic Bacteriuria and Antibiotic Prophylaxis, sponsored by Jorge Andres Ramos Castaneda. Status unknown at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-24.
Sponsored by Jorge Andres Ramos Castaneda · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
Prophylactic antibiotic during five days previous to the procedure.
Procedure: Prophylactic antibiotic during five days previous to the procedure
Prophylactic antibiotic during three days previous to the procedure.
Procedure: Prophylactic antibiotic during three days previous to the procedure
Only a single dose of Prophylactic antibiotic on the day of the procedure
Procedure: Only a single dose of Prophylactic antibiotic
Prophylactic antibiotic during five days previous to the procedure.
Prophylactic antibiotic during three days previous to the procedure.
This group will receive a single dose of antibiotic 90 ± 20 minutes prior to the start of the surgical procedure (incision)
Bloodstream infection
An infectious process characterized by the presence of some bacteria in the bloodstream. The patient should have one or more positive blood cultures, where the cultured organism is not related to an infection elsewhere, and has signs of infection, such as fever, hypotension or tachycardia.
Time frame: 30 days
Surgical Site Infection:
It can occur up to 30 days (or a year when a prosthetic component is involved) of a surgical procedure in some part of the body where it was manipulated in surgery. The SSI is classified as superficial, deep or organ space, depending on the type of tissue involved.
Time frame: 30 days
Length of hospital stay
Difference in days between the date of discharge and of the surgical procedure.
Time frame: 30 days
Re-entry to hospitalization
Re hospitalization after the surgical procedure due to SSI or bloodstream.
Time frame: 30 days
Plan to share: Undecided
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This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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