Prospective Comparative Study About Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-01-31

Brief Summary

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Antimicrobial treatment of asymptomatic bacteriuria (AB) in kidney transplant recipients (KTR) is controversial. The investigators performed a comparative, parallel-group, randomized, open-label study to assess, in a real clinical setting, the feasibility of and benefit derived from systematic search and antimicrobial treatment of all episodes of AB.

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Detailed Description

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All patients undergoing KT between January 2011 and December 2013 in a tertiary-care center with an active transplantation program were systematically searched for AB within the first 2 years after transplantation on a regular basis. During the first 2 months after transplantation all episodes of AB were treated. Thereafter, patients were assigned, according to a computer-generated randomization sequence, to group A (systematic antimicrobial treatment of all episodes of AB) or group B (no treatment). Treatment was chosen according to the results of the urine culture.

Conditions

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Asymptomatic Bacteriuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A: Antibiotic adjusted to antibiogram

A course of 3-14 days of antimicrobial treatment, according to the antibiogram results, will be prescribed for every episode of asymptomatic bacteriuria beyond 2 months after transplantation and during the first 2 years after transplantation

Group Type EXPERIMENTAL

Antibiotic adjusted to antibiogram

Intervention Type OTHER

A course of 3-14 days of antimicrobial treatment, according to the antibiogram results, will be prescribed for every episode of asymptomatic bacteriuria during the first 2 years after transplantation.

B: no treatment

No treatment of any episode of asymptomatic bacteriuria beyond 2 months after transplantation in kidney transplant recipients.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Antibiotic adjusted to antibiogram

A course of 3-14 days of antimicrobial treatment, according to the antibiogram results, will be prescribed for every episode of asymptomatic bacteriuria during the first 2 years after transplantation.

Intervention Type OTHER

Other Intervention Names

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Anti-infective agents

Eligibility Criteria

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Inclusion Criteria

* Adult patients developing asymptomatic bacteriuria beyond 2 months after transplantation.

Exclusion Criteria

* \<18 years old
* Pregnant women
* Kidney-pancreas transplantation
* Double J stent catheterization at the momento of randomization
* Permanent vesical catheter

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No