NCT02373085

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
Last Updated

February 26, 2015

Status Verified

February 1, 2015

Enrollment Period

3.6 years

First QC Date

February 13, 2015

Last Update Submit

February 20, 2015

Conditions

Asymptomatic Bacteriuria

Keywords

Asymptomatic BacteriuriaKidney transplant recipientsPyelonephritis

Outcome Measures

Primary Outcomes (1)

  • Incidence of Pyelonephritis

    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 Outcomes (4)

  • Incidence of lower tract urinary infection

    2 years after transplantation

  • Incidence of Clostridium difficile infection

    2 years after transplantation

  • Incidence of multidrug resistant bacteria colonization/infection

    2 years after transplantation

  • Long-term graft function

    At 1 year and 2 years after transplantation

Study Arms (2)

A: Antibiotic adjusted to antibiogram

EXPERIMENTAL

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

B: no treatment

NO INTERVENTION

No treatment of any episode of asymptomatic bacteriuria beyond 2 months after transplantation in kidney transplant recipients.

Interventions

Antibiotic adjusted to antibiogramOTHER

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.

Also known as: Anti-infective agents
A: Antibiotic adjusted to antibiogram

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients developing asymptomatic bacteriuria beyond 2 months after transplantation.

You may not qualify if:

  • \<18 years old
  • Pregnant women
  • Kidney-pancreas transplantation
  • Double J stent catheterization at the momento of randomization
  • Permanent vesical catheter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27088545DERIVED

MeSH Terms

Conditions

Pyelonephritis

Interventions

Anti-Infective Agents

Condition Hierarchy (Ancestors)

Nephritis, InterstitialNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPyelitisMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Francisco López-Medrano, MD,PhD

    López-Medrano, Francisco, M.D.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lopez-MedranoF

Study Record Dates

First Submitted

February 13, 2015

First Posted

February 26, 2015

Study Start

January 1, 2011

Primary Completion

August 1, 2014

Study Completion

January 1, 2015

Last Updated

February 26, 2015

Record last verified: 2015-02