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

Pyelonephritis Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asymptomatic Bacteriuria
• Bacteriuria
• Pyelonephritis

• NCT number: NCT01771432
• Study type: Interventional
• Source: Hospital Universitari de Bellvitge
• Contact: Núria Sabé Fernàndez
• Phone: +932607625
• Email: nfsabe@bellvitgehospital.cat
• Status: Recruiting
• Phase: N/A
• Start date: January 2013
• Completion date: December 2015