NCT01771432

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 22, 2015

Status Verified

June 1, 2015

Enrollment Period

2.7 years

First QC Date

December 21, 2012

Last Update Submit

June 19, 2015

Conditions

Asymptomatic BacteriuriaPyelonephritis

Outcome Measures

Primary Outcomes (1)

  • To determine the incidence of pyelonephritis in both groups

    First year after kidney transplantation

Secondary Outcomes (4)

  • Renal function

    First year after kydney transplantation

  • Need for hospitalization

    First year after kydney transplantation

  • Incidence of graft loss

    First year after kidney transplantation

  • Mortality

    First year after kidney transplantation

Other Outcomes (1)

  • Infection by multiresistant microorganisms

    First year after kydney transplantation

Study Arms (2)

Antibiotic treatment

ACTIVE COMPARATOR

Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics.

Drug: Antibiotic treatment

No treatment

OTHER

Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy

Other: No treatment

Interventions

Antibiotic treatmentDRUG

Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics

Antibiotic treatment
No treatmentOTHER

Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy

No treatment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who receive a transplant allograft during study period

You may not qualify if:

  • No acceptation of study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Vall d'Hebron

Barcelona, Barcelona, Spain

RECRUITING

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

MeSH Terms

Conditions

Pyelonephritis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Núria Sabé Fernàndez

    Hospital Universitari de Bellvitge

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Núria Sabé Fernàndez

CONTACT

+932607625nfsabe@bellvitgehospital.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Infectious Diseases Phisycian

Study Record Dates

First Submitted

December 21, 2012

First Posted

January 18, 2013

Study Start

January 1, 2013

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

June 22, 2015

Record last verified: 2015-06

Locations

ES(2)