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

Study Overview
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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.

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.

Official Title
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Effect of Systematic Search and Antimicrobial Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients in the Incidence of Acute Pyelonephritis: a Pragmatic Prospective Randomized Controlled Study.

Conditions
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Asymptomatic Bacteriuria

Intervention / Treatment
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* Other: Antibiotic adjusted to antibiogram


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: Antibiotic adjusted to antibiogram<br>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 | Other: Antibiotic adjusted to antibiogram<br>* 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.<br>* Other names: Anti-infective agents;|
| No Intervention: B: no treatment<br>No treatment of any episode of asymptomatic bacteriuria beyond 2 months after transplantation in kidney transplant recipients. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Pyelonephritis | The number of patients that develope pyelonephritis in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization. | 2 years after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of lower tract urinary infection | The number of patients that develope lower tract urinary infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization. | 2 years after transplantation | 
| Incidence of Clostridium difficile infection | The number of patients that develope Clostridium difficile infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization. | 2 years after transplantation | 
| Incidence of multidrug resistant bacteria colonization/infection | The number of patients that develope multidrug resistant bacteria colonization/infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization. | 2 years after transplantation | 
| Long-term graft function | Long-term graft function measured by average serum creatinine at several points until the end of follow-up. | At 1 year and 2 years after transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asymptomatic Bacteriuria, Kidney transplant recipients, Pyelonephritis