Prospective Comparative Study About Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients.

Not Applicable

Completed

• Conditions: Asymptomatic Bacteriuria
• Interventions: Other: Antibiotic adjusted to antibiogram

• Registration Number: NCT02373085
• Lead Sponsor: López-Medrano, Francisco, M.D.

Brief Summary

Antimicrobial treatment of asymptomatic bacteriuria (AB) in kidney transplant recipients (KTR) is controversial. The investigators performed a comparative, parallel-group, randomized, open-label study to assess, in a real clinical setting, the feasibility of and benefit derived from systematic search and antimicrobial treatment of all episodes of AB.

Detailed Description

All patients undergoing KT between January 2011 and December 2013 in a tertiary-care center with an active transplantation program were systematically searched for AB within the first 2 years after transplantation on a regular basis. During the first 2 months after transplantation all episodes of AB were treated. Thereafter, patients were assigned, according to a computer-generated randomization sequence, to group A (systematic antimicrobial treatment of all episodes of AB) or group B (no treatment). Treatment was chosen according to the results of the urine culture.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2014-08
• Study Completion: 2015-01
• Status Verified: 2015-02
• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-02-20
• Last Update Submitted: 2015-02-20
• Study First Posted: 2015-02-26
• Last Update Posted: 2015-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Adult patients developing asymptomatic bacteriuria beyond 2 months after transplantation.

Exclusion Criteria

• <18 years old
• Pregnant women
• Kidney-pancreas transplantation
• Double J stent catheterization at the momento of randomization
• Permanent vesical catheter

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: Antibiotic adjusted to antibiogram	Antibiotic adjusted to antibiogram	A course of 3-14 days of antimicrobial treatment, according to the antibiogram results, will be prescribed for every episode of asymptomatic bacteriuria beyond 2 months after transplantation and during the first 2 years after transplantation

Primary Outcome Measures

Name	Time	Method
Incidence of Pyelonephritis	2 years after transplantation	The number of patients that develope pyelonephritis in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.

Secondary Outcome Measures

Name	Time	Method
Incidence of lower tract urinary infection	2 years after transplantation	The number of patients that develope lower tract urinary infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
Incidence of Clostridium difficile infection	2 years after transplantation	The number of patients that develope Clostridium difficile infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
Incidence of multidrug resistant bacteria colonization/infection	2 years after transplantation	The number of patients that develope multidrug resistant bacteria colonization/infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
Long-term graft function	At 1 year and 2 years after transplantation	Long-term graft function measured by average serum creatinine at several points until the end of follow-up.