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

Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria. A Prospective Randomized Study.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01771432

Acronym

BAC01

Enrollment

200

Registered

2013-01-18

Start date

2013-01-31

Completion date

2015-12-31

Last updated

2015-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic Bacteriuria, Pyelonephritis

Brief summary

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

Detailed description

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.

Interventions

DRUGAntibiotic treatment

Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics

OTHERNo treatment

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Patients who receive a transplant allograft during study period

Exclusion criteria

* No acceptation of study

Design outcomes

Primary

Measure	Time frame
To determine the incidence of pyelonephritis in both groups	First year after kidney transplantation

Secondary

Measure	Time frame
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

Measure	Time frame
Infection by multiresistant microorganisms	First year after kydney transplantation

Countries

Spain

Contacts

Primary ContactNúria Sabé Fernàndez

nfsabe@bellvitgehospital.cat+932607625

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026