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

NCT ID: NCT01771432

Last Updated: 2015-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Asymptomatic Bacteriuria Pyelonephritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Antibiotic treatment

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

Group Type ACTIVE_COMPARATOR

Antibiotic treatment

Intervention Type DRUG

Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics

No treatment

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

Group Type OTHER

No treatment

Intervention Type OTHER

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

Interventions

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Antibiotic treatment

Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics

Intervention Type DRUG

No treatment

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who receive a transplant allograft during study period

Exclusion Criteria

* No acceptation of study
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Núria Sabé Fernàndez

OTHER

Sponsor Role lead

Responsible Party

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Núria Sabé Fernàndez

Infectious Diseases Phisycian

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Núria Sabé Fernàndez

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari de Bellvitge

Locations

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Hospital Vall d'Hebron

Barcelona, Barcelona, Spain

Site Status RECRUITING

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Núria Sabé Fernàndez

Role: CONTACT

+932607625

Facility Contacts

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Núria Sabé Fernàndez

Role: primary

+34932607625

Other Identifiers

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FIS11-1540

Identifier Type: -

Identifier Source: org_study_id

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