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

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

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.

Study Overview

• Status: Completed
• Conditions: Bacteriuria; Kidney Transplantation; Asymptomatic Infections
• Intervention / Treatment: Drug: 7 days course of antibiotic treatment; Drug: 14 days course of antibiotic treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Ratchathewi, Bangkok, Thailand, 10400
      • Pattraporn Ponglorpisit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 7 days course of antibiotic treatment; start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 7 days; Other Names: short-course antibiotic treatment
Active Comparator: 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	Drug: 14 days course of antibiotic treatment; start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 14 days; Other Names: traditional-course antibiotic treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Pattraporn Ponglorpisit, MD, Faculty of Medicine Ramathibodi Hospital, Mahidol University

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: October 8, 2015
• First Submitted That Met QC Criteria: October 11, 2015
• First Posted (Estimate): October 14, 2015

Study Record Updates

• Last Update Posted (Estimate): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 15, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Urologic Diseases; Disease Attributes; Urinary Tract Infections; Asymptomatic Diseases; Bacteriuria; Asymptomatic Infections; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: EC_580278