NCT03269604

Effectiveness of Three Times of Starting Antibiotic Prophylaxis in Patients With Asymptomatic Bacteriuria.

Effectiveness of Three Different Times of Starting Antibiotic Prophylaxis in Patients With Asymptomatic Bacteriuria Scheduled for Urological Surgery. A Randomized Multicentric Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 456 (estimated)
• Sponsor: Jorge Andres Ramos Castaneda · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Asymptomatic Bacteriuria
• Antibiotic Prophylaxis

Interventions

Type	Name	Description
PROCEDURE	Prophylactic antibiotic during five days previous to the procedure	Prophylactic antibiotic during five days previous to the procedure.
PROCEDURE	Prophylactic antibiotic during three days previous to the procedure	Prophylactic antibiotic during three days previous to the procedure.
PROCEDURE	Only a single dose of Prophylactic antibiotic	This group will receive a single dose of antibiotic 90 ± 20 minutes prior to the start of the surgical procedure (incision)

Timeline

• Start date: 2018-01-22
• Primary completion: 2018-10-01
• Completion: 2018-11-01
• First posted: 2017-09-01
• Last updated: 2018-01-24

Locations

1 site across 1 country: Colombia