A Randomized Control Trial of Antibiotic Treatment Duration For Asymptomatic Bacteriuria After Kidney Transplantation

Study Overview
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Brief Summary
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The major hypothesis to be tested is that there was no difference in the clinical outcome between 7(short-course) and 14(traditional-course) days of antibiotic treatment for asymptomatic bacteriuria early after kidney transplantation.

Detailed Description
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Introduction: Treatment of asymptomatic bacteriuria is a common practice in renal transplant centers leading to prolong exposure of antimicrobial agents with long hospital length of stay. The duration of antibiotics treatment in this condition have never been proposed. Objective: To evaluate the proper duration of antibiotic treatment for asymptomatic bacteriuria early (less than 1 month) after kidney transplantation Method: This is a prospective, randomized, open labeled, single center study using intention to treat analysis. Patients will be identified and after informed consent is obtained, will be randomized to receive 7 or 14 days course of antibiotics.

Official Title
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A Pilot Randomized Control Study of Shortening Antibiotic Treatment Duration For Asymptomatic Bacteriuria Within A Month After Kidney Transplantation

Conditions
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Kidney Transplantation, Bacteriuria, Asymptomatic Infections

Intervention / Treatment
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* Drug: 7 days course of antibiotic treatment
* Drug: 14 days course of antibiotic treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First kidney transplantation Asymptomatic bacteriuria Exclusion Criteria: Refusal to participate in the study Re-transplantation or combined organ transplantation History of abnormal structure or function in native kidney, ureter and bladder system Kidney transplant recipients with history of recurrent urinary tract infection or incomplete course of urinary tract infection treatment before transplantation Hemodynamic unstable Urosepsis or other serious infectious complications(eg. symptomatic urinary tract infection/graft pyelonephritis, surgical site infection, infected urinoma/ hospital acquired pneumonia that mandates antibiotic therapy) Surgical complication (eg. anastomosis leakage, collection, ureteric stricture)

Ages Eligible for Study
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Minimum Age: 15 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 7 days course of antibiotic treatment<br>To assign the 7 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture | Drug: 7 days course of antibiotic treatment<br>* start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 7 days<br>* Other names: short-course antibiotic treatment;|
| Active Comparator: 14 days course of antibiotic treatment<br>To assign the 14 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture | Drug: 14 days course of antibiotic treatment<br>* start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 14 days<br>* Other names: traditional-course antibiotic treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate | Composite end point at 1 month after discontinuing antibiotics | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate | Composite end point at 0.5 months after discontinuing antibiotics | 0.5 months | 
| Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and | Composite end point at 3 months after discontinuing antibiotics | 3 months | 
| duration of hospital stay | duration of hospital stay | 30 days since randomization |