Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria (BAC01)

N

Núria Sabé Fernàndez

Status

Unknown

Conditions

Asymptomatic Bacteriuria
Pyelonephritis

Treatments

Other: No treatment
Drug: Antibiotic treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01771432
FIS11-1540

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who receive a transplant allograft during study period

Exclusion criteria

  • No acceptation of study

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Antibiotic treatment
Active Comparator group
Description:
Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics.
Treatment:
Drug: Antibiotic treatment
No treatment
Other group
Description:
Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy
Treatment:
Other: No treatment

Trial contacts and locations

2

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Central trial contact

Núria Sabé Fernàndez

Data sourced from clinicaltrials.gov

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