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

NCT ID: NCT02113774

Last Updated: 2014-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Tract Infection Bacteriuria Renal Transplantation

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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no therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

antimicrobial treatment according to in-vitro susceptibility

Group Type ACTIVE_COMPARATOR

antimicrobial treatment according to in-vitro susceptibility

Intervention Type OTHER

Interventions

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antimicrobial treatment according to in-vitro susceptibility

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ruth Rahamimov

head of transplant investigator service

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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7687

Identifier Type: -

Identifier Source: org_study_id

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