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

Phase 2

Completed

• Conditions: Kidney Transplantation; Bacteriuria; Asymptomatic Infections
• Interventions: Drug: 7 days course of antibiotic treatment; Drug: 14 days course of antibiotic treatment

• Registration Number: NCT02575495
• Lead Sponsor: Mahidol University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-10-11
• Study First Posted: 2015-10-14
• Primary Completion: 2016-01
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• First kidney transplantation
• Asymptomatic bacteriuria

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
7 days course of antibiotic treatment	7 days course of antibiotic treatment	To assign the 7 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture
14 days course of antibiotic treatment	14 days course of antibiotic treatment	To assign the 14 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture

Primary Outcome Measures

Name	Time	Method
Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate	1 month	Composite end point at 1 month after discontinuing antibiotics

Secondary Outcome Measures

Name	Time	Method
Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate	0.5 months	Composite end point at 0.5 months after discontinuing antibiotics
Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and	3 months	Composite end point at 3 months after discontinuing antibiotics
duration of hospital stay	30 days since randomization	duration of hospital stay

Trial Locations

Locations (1)

Pattraporn Ponglorpisit; 🇹🇭 Ratchathewi, Bangkok, Thailand