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

Effect of Systematic Search and Antimicrobial Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients in the Incidence of Acute Pyelonephritis: a Pragmatic Prospective Randomized Controlled Study.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02373085

Enrollment

112

Registered

2015-02-26

Start date

2011-01-31

Completion date

2015-01-31

Last updated

2015-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic Bacteriuria

Keywords

Asymptomatic Bacteriuria, Kidney transplant recipients, Pyelonephritis

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.

Interventions

OTHERAntibiotic 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 during the first 2 years after transplantation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026