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

Pyelonephritis Clinical Trial

— BAC01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01771432
• Other study ID #: FIS11-1540
• Status: Recruiting
• Phase: N/A
• First received: December 21, 2012
• Last updated: June 19, 2015
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: June 2015
• Source: Hospital Universitari de Bellvitge
• Contact: Núria Sabé Fernàndez
• Phone: +932607625
• Email: nfsabe[@]bellvitgehospital.cat
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos SanitariosSpain: Comité Ético de Investigación Clínica
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients who receive a transplant allograft during study period

Exclusion Criteria:

• No acceptation of study

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

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Núria Sabé Fernàndez

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infection by multiresistant microorganisms		First year after kydney transplantation	No
Primary	To determine the incidence of pyelonephritis in both groups		First year after kidney transplantation	Yes
Secondary	Renal function		First year after kydney transplantation	Yes
Secondary	Need for hospitalization		First year after kydney transplantation	Yes
Secondary	Incidence of graft loss		First year after kidney transplantation	Yes
Secondary	Mortality		First year after kidney transplantation	Yes