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

February 20, 2015 updated by: Francisco López Medrano, López-Medrano, Francisco, M.D.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A: 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
Other: 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 during the first 2 years after transplantation.
Other Names:
  • Anti-infective agents
No Intervention: B: no treatment
No treatment of any episode of asymptomatic bacteriuria beyond 2 months after transplantation in kidney transplant recipients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Pyelonephritis
Time Frame: 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.
2 years after transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of lower tract urinary infection
Time Frame: 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.
2 years after transplantation
Incidence of Clostridium difficile infection
Time Frame: 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.
2 years after transplantation
Incidence of multidrug resistant bacteria colonization/infection
Time Frame: 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.
2 years after transplantation
Long-term graft function
Time Frame: 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.
At 1 year and 2 years after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

López-Medrano, Francisco, M.D.

Investigators

  • Principal Investigator: Francisco López-Medrano, MD,PhD, López-Medrano, Francisco, M.D.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

February 13, 2015

First Submitted That Met QC Criteria

February 20, 2015

First Posted (Estimate)

February 26, 2015

Study Record Updates

Last Update Posted (Estimate)

February 26, 2015

Last Update Submitted That Met QC Criteria

February 20, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABTxR-H12O

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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