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

NCT ID: NCT03269604

Last Updated: 2018-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-22
• Study Completion Date: 2018-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Prophylactic antibiotic five days previous to the procedure

Prophylactic antibiotic during five days previous to the procedure.

Group Type: ACTIVE_COMPARATOR

Prophylactic antibiotic during five days previous to the procedure

Intervention Type: PROCEDURE

Prophylactic antibiotic during five days previous to the procedure.

Prophylactic antibiotic three days previous to the procedure

Prophylactic antibiotic during three days previous to the procedure.

Group Type: ACTIVE_COMPARATOR

Prophylactic antibiotic during three days previous to the procedure

Intervention Type: PROCEDURE

Prophylactic antibiotic during three days previous to the procedure.

Only a single dose of Prophylactic antibiotic

Only a single dose of Prophylactic antibiotic on the day of the procedure

Group Type: EXPERIMENTAL

Only a single dose of Prophylactic antibiotic

Intervention Type: PROCEDURE

This group will receive a single dose of antibiotic 90 ± 20 minutes prior to the start of the surgical procedure (incision)

Interventions

Prophylactic antibiotic during five days previous to the procedure

Prophylactic antibiotic during five days previous to the procedure.

Intervention Type: PROCEDURE

Prophylactic antibiotic during three days previous to the procedure

Prophylactic antibiotic during three days previous to the procedure.

Intervention Type: 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)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Patients with asymptomatic bacteriuria identified with a urine culture prior to the surgical procedure and with a microorganism that meets the following criteria: 1) gram-negative bacteria in the enterobacterial family and non-fermenting bacilli; 2) Bacteria with resistance profile has a therapeutic option that reaches therapeutic concentration in urine.
• Patients scheduled for urological procedures, such as: transurethral resection of the prostate, open prostatectomy, cystoscopy, extracorporeal lithotripsy and flexible ureterorenoscopy.
• Informed consent

Exclusion Criteria

• Patients with chronic renal failure; with immunosuppressive status secondary to glucocorticoid consumption, haematological or solid organ neoplasms undergoing chemotherapy or radiation therapy or neutropenia.
• Patients with active infection or clinical criteria of urinary infection.
• Patients who voluntarily do not want to participate in the study.
• Patients who can not give informed consent under reasonable or vulnerable conditions.
• Patients who present type I allergy to penicillin.
• Patients who have scheduled surgeries combined with a discipline different to urology.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jorge Andres Ramos Castaneda

OTHER

Sponsor Role: lead

Responsible Party

Jorge Andres Ramos Castaneda

Ph. D. student in Public Health

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Universidad CES

Medellín, Antioquia, Colombia

Site Status: RECRUITING

Countries

Colombia

Facility Contacts

Jorge A Ramos, Ph.D Stud

Role: primary

ramos.jorge@uces.edu.co

+57 (4) 4440555

Other Identifiers

1075237598

Identifier Type: -

Identifier Source: org_study_id