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

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ClinicalTrials.gov Identifier: NCT03269604
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Jorge Andres Ramos Castaneda, CES University

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.


Condition or disease Intervention/treatment Phase
Asymptomatic Bacteriuria Antibiotic Prophylaxis 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: A single blinding will be performed. To the database will be categorized the variable "duration of prophylaxis" so that the person in charge of analysing the data, does not know the true allocation of each of the participants. At the end of the tabulation and analysis of the data, the true allocation will be known.
Primary Purpose: Prevention
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
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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)




Primary Outcome Measures :
  1. Bloodstream infection [ Time Frame: 30 days ]
    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.


Secondary Outcome Measures :
  1. Surgical Site Infection: [ Time Frame: 30 days ]
    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.

  2. Length of hospital stay [ Time Frame: 30 days ]
    Difference in days between the date of discharge and of the surgical procedure.

  3. Re-entry to hospitalization [ Time Frame: 30 days ]
    Re hospitalization after the surgical procedure due to SSI or bloodstream.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269604


Locations
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Colombia
Universidad CES Recruiting
Medellín, Antioquia, Colombia, 00000
Contact: Jorge A Ramos, Ph.D Stud    +57 (4) 4440555    ramos.jorge@uces.edu.co   
Principal Investigator: Jorge A Ramos, Ph.D Stud         
Sponsors and Collaborators
Jorge Andres Ramos Castaneda

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Responsible Party: Jorge Andres Ramos Castaneda, Ph. D. student in Public Health, CES University
ClinicalTrials.gov Identifier: NCT03269604     History of Changes
Other Study ID Numbers: 1075237598
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jorge Andres Ramos Castaneda, CES University:
Urological Surgery
Bacterial resistance

Additional relevant MeSH terms:
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Bacteriuria
Urinary Tract Infections
Infection
Urologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents