Back to resultsAntibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria (BAC01)
Primary Purpose
Asymptomatic Bacteriuria, Pyelonephritis
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Antibiotic treatment
No treatment
Sponsored by
About this trial
This is an interventional prevention trial for Asymptomatic Bacteriuria
Eligibility Criteria
Inclusion Criteria:
- Patients who receive a transplant allograft during study period
Exclusion Criteria:
- No acceptation of study
Sites / Locations
- Hospital Universitari de BellvitgeRecruiting
- Hospital Vall d'HebronRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Antibiotic treatment
No treatment
Arm Description
Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics.
Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy
Outcomes
Primary Outcome Measures
To determine the incidence of pyelonephritis in both groups
Secondary Outcome Measures
Renal function
Need for hospitalization
Incidence of graft loss
Mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01771432
Brief Title
Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria
Acronym
BAC01
Official Title
Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria. A Prospective Randomized Study.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Núria Sabé Fernàndez
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asymptomatic Bacteriuria, Pyelonephritis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Antibiotic treatment
Arm Type
Active Comparator
Arm Description
Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics.
Arm Title
No treatment
Arm Type
Other
Arm Description
Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy
Intervention Type
Drug
Intervention Name(s)
Antibiotic treatment
Intervention Description
Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics
Intervention Type
Other
Intervention Name(s)
No treatment
Intervention Description
Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy
Primary Outcome Measure Information:
Title
To determine the incidence of pyelonephritis in both groups
Time Frame
First year after kidney transplantation
Secondary Outcome Measure Information:
Title
Renal function
Time Frame
First year after kydney transplantation
Title
Need for hospitalization
Time Frame
First year after kydney transplantation
Title
Incidence of graft loss
Time Frame
First year after kidney transplantation
Title
Mortality
Time Frame
First year after kidney transplantation
Other Pre-specified Outcome Measures:
Title
Infection by multiresistant microorganisms
Time Frame
First year after kydney transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who receive a transplant allograft during study period
Exclusion Criteria:
No acceptation of study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Núria Sabé Fernàndez
Phone
+932607625
Email
nfsabe@bellvitgehospital.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Núria Sabé Fernàndez
Organizational Affiliation
Hospital Universitari de Bellvitge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Núria Sabé Fernàndez
Phone
+34932607625
Email
nfsabe@bellvitgehsopital.cat
Facility Name
Hospital Vall d'Hebron
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria
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