Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria (BAC01)

June 19, 2015 updated by: Núria Sabé Fernàndez

Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria. A Prospective Randomized Study.

Objective: To determine whether antibiotic treatment of asymptomatic bacteriuria in kidney transplant recipients could be useful to prevent pyelonephritis in these patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Design: Randomized prospective study. Setting: University Hospital with an active kidney transplantation program. Patients: Adult kidney transplant recipients. Interventions: Kidney transplant recipients with asymptomatic bacteriuria will be randomly assigned to be treated with antibiotics or to be followed without antibiotic therapy.

Measurements: Urine cultures will be collected weekly during the first month after transplantation, every 2 weeks until three months after transplantation, every month until 6 months after transplantation and every 3 months until 12 months after transplantation. Urine culture will be as well collected if urinary symptoms appeared.

Primary end points: To determine in both groups: the incidence of pyelonephritis.

Secondary end points: To determine outcomes in both groups (renal function, hospitalization, rejection, graft loss, opportunistic infections and mortality) and infection by multiresistant microorganisms.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Vall d'Hebron
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Hospital Universitari de Bellvitge
        • Contact:

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who receive a transplant allograft during study period

Exclusion Criteria:

  • No acceptation of study

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
Active Comparator: Antibiotic treatment
Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics.
Drug: Antibiotic treatment
Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics
Other: No treatment
Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy
Other: No treatment
Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the incidence of pyelonephritis in both groups
Time Frame: First year after kidney transplantation
First year after kidney transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Renal function
Time Frame: First year after kydney transplantation
First year after kydney transplantation
Need for hospitalization
Time Frame: First year after kydney transplantation
First year after kydney transplantation
Incidence of graft loss
Time Frame: First year after kidney transplantation
First year after kidney transplantation
Mortality
Time Frame: First year after kidney transplantation
First year after kidney transplantation

Other Outcome Measures

Outcome Measure
Time Frame
Infection by multiresistant microorganisms
Time Frame: First year after kydney transplantation
First year after kydney transplantation

Collaborators and Investigators

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

Sponsor

Núria Sabé Fernàndez

Investigators

  • Principal Investigator: Núria Sabé Fernàndez, Hospital Universitari de Bellvitge

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, 2013

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

December 21, 2012

First Submitted That Met QC Criteria

January 16, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Estimate)

June 22, 2015

Last Update Submitted That Met QC Criteria

June 19, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIS11-1540

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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