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

Not Applicable

• Conditions: Pyelonephritis; Asymptomatic Bacteriuria
• Interventions: Drug: Antibiotic treatment; Other: No treatment

• Registration Number: NCT01771432
• Lead Sponsor: Núria Sabé Fernàndez

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.

Study Timeline

• Study First Submitted: 2012-12-21
• Study Start: 2013-01
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-18
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-19
• Last Update Posted: 2015-06-22
• Primary Completion: 2015-09
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients who receive a transplant allograft during study period

Exclusion Criteria

• No acceptation of study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotic treatment	Antibiotic treatment	Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics.
No treatment	No treatment	Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy

Primary Outcome Measures

Name	Time	Method
To determine the incidence of pyelonephritis in both groups	First year after kidney transplantation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain