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

Mahidol University20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Transplantation Bacteriuria Asymptomatic Infections

Interventions

7 days course of antibiotic treatmentDRUG

start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 7 days

14 days course of antibiotic treatmentDRUG

start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 14 days

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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)

Locations (1)

Pattraporn Ponglorpisit

Ratchathewi, Bangkok, Thailand

Outcomes

Primary Outcomes

Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate

Composite end point at 1 month after discontinuing antibiotics

Time frame: 1 month

Secondary Outcomes

Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate

Composite end point at 0.5 months after discontinuing antibiotics

Time frame: 0.5 months

Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and

Composite end point at 3 months after discontinuing antibiotics

Time frame: 3 months

duration of hospital stay

Time frame: 30 days since randomization

Data from ClinicalTrials.gov

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