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

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ClinicalTrials.gov Identifier: NCT01771432
Recruitment Status : Unknown
Verified June 2015 by Núria Sabé Fernàndez, Hospital Universitari de Bellvitge.
Recruitment status was:  Recruiting
First Posted : January 18, 2013
Last Update Posted : June 22, 2015
Sponsor:
Information provided by (Responsible Party):
Núria Sabé Fernàndez, Hospital Universitari de Bellvitge

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

Condition or disease Intervention/treatment Phase
Asymptomatic Bacteriuria Pyelonephritis Drug: Antibiotic treatment Other: No treatment Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria. A Prospective Randomized Study.
Study Start Date : January 2013
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. To determine the incidence of pyelonephritis in both groups [ Time Frame: First year after kidney transplantation ]

Secondary Outcome Measures :
  1. Renal function [ Time Frame: First year after kydney transplantation ]
  2. Need for hospitalization [ Time Frame: First year after kydney transplantation ]
  3. Incidence of graft loss [ Time Frame: First year after kidney transplantation ]
  4. Mortality [ Time Frame: First year after kidney transplantation ]

Other Outcome Measures:
  1. Infection by multiresistant microorganisms [ Time Frame: First year after kydney transplantation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who receive a transplant allograft during study period

Exclusion Criteria:

  • No acceptation of study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771432


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

Locations
Spain
Hospital Universitari de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Núria Sabé Fernàndez    +34932607625    nfsabe@bellvitgehsopital.cat   
Hospital Vall d'Hebron Recruiting
Barcelona, Spain
Sponsors and Collaborators
Núria Sabé Fernàndez
Investigators
Principal Investigator: Núria Sabé Fernàndez Hospital Universitari de Bellvitge

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
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: June 22, 2015
Last Verified: June 2015

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
Antitubercular Agents