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

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.

Study Overview

• Status: Unknown
• Conditions: Asymptomatic Bacteriuria; Antibiotic Prophylaxis
• Intervention / Treatment: Procedure: Prophylactic antibiotic during five days previous to the procedure; Procedure: Prophylactic antibiotic during three days previous to the procedure; Procedure: Only a single dose of Prophylactic antibiotic

• Study Type: Interventional
• Enrollment (Anticipated): 456
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 00000
      • Recruiting
      • Universidad CES
      • Contact: Jorge A Ramos, Ph.D Stud; Phone Number: +57 (4) 4440555; Email: ramos.jorge@uces.edu.co
      • Principal Investigator: Jorge A Ramos, Ph.D Stud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prophylactic antibiotic five days previous to the procedure; Prophylactic antibiotic during five days previous to the procedure.	Procedure: Prophylactic antibiotic during five days previous to the procedure; Prophylactic antibiotic during five days previous to the procedure.
Active Comparator: Prophylactic antibiotic three days previous to the procedure; Prophylactic antibiotic during three days previous to the procedure.	Procedure: Prophylactic antibiotic during three days previous to the procedure; Prophylactic antibiotic during three days previous to the procedure.
Experimental: Only a single dose of Prophylactic antibiotic; Only a single dose of Prophylactic antibiotic on the day of 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days
Length of hospital stay	Difference in days between the date of discharge and of the surgical procedure.	30 days
Re-entry to hospitalization	Re hospitalization after the surgical procedure due to SSI or bloodstream.	30 days

Collaborators and Investigators

• Sponsor: Jorge Andres Ramos Castaneda

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): January 24, 2018
• Last Update Submitted That Met QC Criteria: January 22, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Urological Surgery; Bacterial resistance
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections; Bacteriuria; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: 1075237598

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No