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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by Hospital Universitari de Bellvitge
Sponsor:
Information provided by (Responsible Party):
Núria Sabé Fernàndez, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01771432
First received: December 21, 2012
Last updated: January 16, 2013
Last verified: December 2012
  Purpose

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


Condition Intervention
Asymptomatic Bacteriuria
Pyelonephritis
Drug: Antibiotic treatment
Other: No treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria. A Prospective Randomized Study.

Resource links provided by NLM:


Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • To determine the incidence of pyelonephritis in both groups [ Time Frame: First year after kidney transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Renal function [ Time Frame: First year after kydney transplantation ] [ Designated as safety issue: Yes ]
  • Need for hospitalization [ Time Frame: First year after kydney transplantation ] [ Designated as safety issue: Yes ]
  • Incidence of graft loss [ Time Frame: First year after kidney transplantation ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: First year after kidney transplantation ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Infection by multiresistant microorganisms [ Time Frame: First year after kydney transplantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Antibiotic treatment
Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics.
Drug: Antibiotic treatment
Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics
No treatment
Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy
Other: No treatment
Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who receive a transplant allograft during study period

Exclusion Criteria:

  • No acceptation of study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771432

Contacts
Contact: Núria Sabé Fernàndez +932607625 nfsabe@bellvitgehospital.cat

Locations
Spain
Hospital Universitari de Bellvitge Not yet recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Núria Sabé Fernàndez    +34932607625    nfsabe@bellvitgehsopital.cat   
Hospital Universitari de Bellvitge Not yet recruiting
L'Hospitalet de Llobregat., Barcelona, Spain, 08907
Principal Investigator: Núria Sabé Fernàndez         
Sponsors and Collaborators
Núria Sabé Fernàndez
Investigators
Principal Investigator: Núria Sabé Fernàndez Hospital Universitari de Bellvitge
  More Information

No publications provided

Responsible Party: Núria Sabé Fernàndez, Infectious Diseases Phisycian, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT01771432     History of Changes
Other Study ID Numbers: FIS11-1540
Study First Received: December 21, 2012
Last Updated: January 16, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Pyelonephritis
Bacteriuria
Nephritis, Interstitial
Nephritis
Kidney Diseases
Urologic Diseases
Pyelitis
Urinary Tract Infections
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on September 29, 2014