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Completed

NCT Number: NCT02373085

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

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.

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Key information

Conditions

Asymptomatic Bacteriuria Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephritis Nephritis, Interstitial Pyelitis Pyelonephritis Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic adjusted to antibiogram

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

López-Medrano, Francisco, M.D.

Indiv

Registry information

Official study title

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.

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Feb 26, 2015
Registry last updated
Feb 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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