Clinical trial NCT03269604: Effectiveness of Three Times of Starting Antibiotic Prophylaxis in Patients With Asymptomatic Bacteriuria.
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asymptomatic Bacteriuria
Antibiotic Prophylaxis
Keywords: Urological Surgery
Bacterial resistance
Lead sponsor: CES University
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Bloodstream infection
timeFrame: 30 days
Secondary outcomes:
measure: Surgical Site Infection:
timeFrame: 30 days
measure: Length of hospital stay
timeFrame: 30 days
measure: Re-entry to hospitalization
timeFrame: 30 days
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Universidad CES
state: Antioquia
Study officials:
References: