NCT01771432

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Núria Sabé Fernàndez · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asymptomatic Bacteriuria
• Pyelonephritis

Interventions

Type	Name	Description
DRUG	Antibiotic treatment	Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics
OTHER	No treatment	Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-09-01
• Completion: 2015-12-01
• First posted: 2013-01-18
• Last updated: 2015-06-22

Locations

2 sites across 1 country: Spain