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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575495
• Other study ID #: EC_580278
• Status: Completed
• Phase: Phase 2
• First received: October 8, 2015
• Last updated: March 15, 2016
• Start date: February 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asymptomatic Infections
• Bacteriuria
• Kidney Transplantation

Intervention

Drug:
• 7 days course of antibiotic treatment
start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 7 days
• 14 days course of antibiotic treatment
start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 14 days

Locations

Country	Name	City	State
Thailand	Pattraporn Ponglorpisit	Ratchathewi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and	Composite end point at 3 months after discontinuing antibiotics	3 months	Yes
Secondary	duration of hospital stay	duration of hospital stay	30 days since randomization	No