Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria

Study Overview
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Brief Summary
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Objective: To determine whether antibiotic treatment of asymptomatic bacteriuria in kidney transplant recipients could be useful to prevent pyelonephritis in these patients.

Detailed Description
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Design: Randomized prospective study. Setting: University Hospital with an active kidney transplantation program. Patients: Adult kidney transplant recipients. Interventions: Kidney transplant recipients with asymptomatic bacteriuria will be randomly assigned to be treated with antibiotics or to be followed without antibiotic therapy. Measurements: Urine cultures will be collected weekly during the first month after transplantation, every 2 weeks until three months after transplantation, every month until 6 months after transplantation and every 3 months until 12 months after transplantation. Urine culture will be as well collected if urinary symptoms appeared. Primary end points: To determine in both groups: the incidence of pyelonephritis. Secondary end points: To determine outcomes in both groups (renal function, hospitalization, rejection, graft loss, opportunistic infections and mortality) and infection by multiresistant microorganisms.

Official Title
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Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria. A Prospective Randomized Study.

Conditions
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Asymptomatic Bacteriuria, Pyelonephritis

Intervention / Treatment
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* Drug: Antibiotic treatment
* Other: No treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who receive a transplant allograft during study period Exclusion Criteria: No acceptation of study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Active Comparator: Antibiotic treatment<br>Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics. | Drug: Antibiotic treatment<br>* Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics<br>|
| Other: No treatment<br>Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy | Other: No treatment<br>* Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the incidence of pyelonephritis in both groups |  | First year after kidney transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function |  | First year after kydney transplantation | 
| Need for hospitalization |  | First year after kydney transplantation | 
| Incidence of graft loss |  | First year after kidney transplantation | 
| Mortality |  | First year after kidney transplantation |