Clinical trial NCT02373085: Prospective Comparative Study About Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asymptomatic Bacteriuria
Keywords: Asymptomatic Bacteriuria
Kidney transplant recipients
Pyelonephritis
Lead sponsor: López-Medrano, Francisco, M.D.
Sponsor class: INDIV
First posted: 2015-02-26
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Pyelonephritis
timeFrame: 2 years after transplantation
Secondary outcomes:
measure: Incidence of lower tract urinary infection
timeFrame: 2 years after transplantation
measure: Incidence of Clostridium difficile infection
timeFrame: 2 years after transplantation
measure: Incidence of multidrug resistant bacteria colonization/infection
timeFrame: 2 years after transplantation
measure: Long-term graft function
timeFrame: At 1 year and 2 years after transplantation
Other outcomes:
Locations:
Study officials:
affiliation: López-Medrano, Francisco, M.D.
name: Francisco López-Medrano, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Origuen J, Lopez-Medrano F, Fernandez-Ruiz M, Polanco N, Gutierrez E, Gonzalez E, Merida E, Ruiz-Merlo T, Morales-Cartagena A, Perez-Jacoiste Asin MA, Garcia-Reyne A, San Juan R, Orellana MA, Andres A, Aguado JM. Should Asymptomatic Bacteriuria Be Systematically Treated in Kidney Transplant Recipients? Results From a Randomized Controlled Trial. Am J Transplant. 2016 Oct;16(10):2943-2953. doi: 10.1111/ajt.13829. Epub 2016 May 23.