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Prospective Comparative Study About Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients.

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ClinicalTrials.gov Identifier: NCT02373085
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
Sponsor:
Information provided by (Responsible Party):
Francisco López Medrano, López-Medrano, Francisco, M.D.

Tracking Information
First Submitted Date  ICMJE February 13, 2015
First Posted Date  ICMJE February 26, 2015
Last Update Posted Date February 26, 2015
Study Start Date  ICMJE January 2011
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2015)		 Incidence of Pyelonephritis [ Time Frame: 2 years after transplantation ]
The number of patients that develope pyelonephritis in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
  • Incidence of lower tract urinary infection [ Time Frame: 2 years after transplantation ]
    The number of patients that develope lower tract urinary infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
  • Incidence of Clostridium difficile infection [ Time Frame: 2 years after transplantation ]
    The number of patients that develope Clostridium difficile infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
  • Incidence of multidrug resistant bacteria colonization/infection [ Time Frame: 2 years after transplantation ]
    The number of patients that develope multidrug resistant bacteria colonization/infection in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
  • Long-term graft function [ Time Frame: At 1 year and 2 years after transplantation ]
    Long-term graft function measured by average serum creatinine at several points until the end of follow-up.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Comparative Study About Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients.
Official Title  ICMJE Effect of Systematic Search and Antimicrobial Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients in the Incidence of Acute Pyelonephritis: a Pragmatic Prospective Randomized Controlled Study.
Brief Summary Antimicrobial treatment of asymptomatic bacteriuria (AB) in kidney transplant recipients (KTR) is controversial. The investigators performed a comparative, parallel-group, randomized, open-label study to assess, in a real clinical setting, the feasibility of and benefit derived from systematic search and antimicrobial treatment of all episodes of AB.
Detailed Description All patients undergoing KT between January 2011 and December 2013 in a tertiary-care center with an active transplantation program were systematically searched for AB within the first 2 years after transplantation on a regular basis. During the first 2 months after transplantation all episodes of AB were treated. Thereafter, patients were assigned, according to a computer-generated randomization sequence, to group A (systematic antimicrobial treatment of all episodes of AB) or group B (no treatment). Treatment was chosen according to the results of the urine culture.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Asymptomatic Bacteriuria
Intervention  ICMJE Other: Antibiotic adjusted to antibiogram
A course of 3-14 days of antimicrobial treatment, according to the antibiogram results, will be prescribed for every episode of asymptomatic bacteriuria during the first 2 years after transplantation.
Other Name: Anti-infective agents
Study Arms  ICMJE
  • Experimental: A: Antibiotic adjusted to antibiogram
    A course of 3-14 days of antimicrobial treatment, according to the antibiogram results, will be prescribed for every episode of asymptomatic bacteriuria beyond 2 months after transplantation and during the first 2 years after transplantation
    Intervention: Other: Antibiotic adjusted to antibiogram
  • No Intervention: B: no treatment
    No treatment of any episode of asymptomatic bacteriuria beyond 2 months after transplantation in kidney transplant recipients.
Publications * Origüen J, López-Medrano F, Fernández-Ruiz M, Polanco N, Gutiérrez E, González E, Mérida E, Ruiz-Merlo T, Morales-Cartagena A, Pérez-Jacoiste Asín MA, García-Reyne A, San Juan R, Orellana MÁ, Andrés A, Aguado JM. Should Asymptomatic Bacteriuria Be Systematically Treated in Kidney Transplant Recipients? Results From a Randomized Controlled Trial. Am J Transplant. 2016 Oct;16(10):2943-2953. doi: 10.1111/ajt.13829. Epub 2016 May 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2015)		 112
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients developing asymptomatic bacteriuria beyond 2 months after transplantation.

Exclusion Criteria:

  • <18 years old
  • Pregnant women
  • Kidney-pancreas transplantation
  • Double J stent catheterization at the momento of randomization
  • Permanent vesical catheter
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02373085
Other Study ID Numbers  ICMJE ABTxR-H12O
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Francisco López Medrano, López-Medrano, Francisco, M.D.
Study Sponsor  ICMJE López-Medrano, Francisco, M.D.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francisco López-Medrano, MD,PhD López-Medrano, Francisco, M.D.
PRS Account López-Medrano, Francisco, M.D.
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP