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

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)

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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