The Impact of Antimicrobial Treatment for Asymptomatic Bacteriuria in Renal Transplant Patients

April 14, 2014 updated by: Ruth Rahamimov, Rabin Medical Center
The investigators hypothesize that antibiotic therapy for asymptomatic bacteriuria in renal transplant patients does not have impact on the development of symptomatic urinary tract infection (UTI) or progression of renal impairment in patients during the first year after transplantation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are ≥1 month and ≤ 12 months after renal transplantation.
  • Positive urine culture defined as ≥ 105 colony forming units (CFU) per milliliter of a known single pathogen.

Exclusion Criteria:

  • Any one of the following signs and symptoms: fever, abdominal pain, dysuria, frequency, urgency, flank pain, costovertebral-angel tenderness or tenderness over the transplanted kidney
  • Active infections in another site
  • Leucocytosis (WBC >18.000K/micl) or leucopenia (WBC < 3.000 K/micl)
  • Elevation of serum creatinine of more than 15% of its baseline level
  • Obstructive or other urological complications following transplantation as known foreign device (stent/double-J-Cath, any catheter) in the urinary tract system, known obstruction of the transplanted kidney, indwelling or intermittent catheterization
  • Pregnant or lactating women.
  • Candidates to invasive urologic procedures.
  • Inability to return for regular follow up.
  • Previous enrollment in this study.
  • Patients who incapable of giving informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: no therapy
Active Comparator: antimicrobial treatment according to in-vitro susceptibility
Other: antimicrobial treatment according to in-vitro susceptibility

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
development of symptomatic urinary tract infection
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
25% reduction in estimated glomerular filtration rate (eGFR)
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Time Frame
graft loss
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

March 23, 2014

First Submitted That Met QC Criteria

April 14, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Estimate)

April 15, 2014

Last Update Submitted That Met QC Criteria

April 14, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7687

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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