Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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.

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.

Condition or disease Intervention/treatment Phase
Asymptomatic Bacteriuria Other: Antibiotic adjusted to antibiogram Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : January 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

No Intervention: B: no treatment
No treatment of any episode of asymptomatic bacteriuria beyond 2 months after transplantation in kidney transplant recipients.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02373085


Sponsors and Collaborators
López-Medrano, Francisco, M.D.
Investigators
Layout table for investigator information
Principal Investigator: Francisco López-Medrano, MD,PhD López-Medrano, Francisco, M.D.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Francisco López Medrano, Lopez-MedranoF, López-Medrano, Francisco, M.D.
ClinicalTrials.gov Identifier: NCT02373085     History of Changes
Other Study ID Numbers: ABTxR-H12O
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015

Keywords provided by Francisco López Medrano, López-Medrano, Francisco, M.D.:
Asymptomatic Bacteriuria
Kidney transplant recipients
Pyelonephritis

Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pyelonephritis
Bacteriuria
Nephritis, Interstitial
Nephritis
Kidney Diseases
Urologic Diseases
Pyelitis
Urinary Tract Infections
Infection