NCT02113774

Brief Summary

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.

Trial Health

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Status
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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Last Updated

April 15, 2014

Status Verified

April 1, 2014

Enrollment Period

5 years

First QC Date

March 23, 2014

Last Update Submit

April 14, 2014

Conditions

Urinary Tract InfectionBacteriuriaRenal Transplantation

Outcome Measures

Primary Outcomes (1)

  • development of symptomatic urinary tract infection

    30 days

Secondary Outcomes (1)

  • 25% reduction in estimated glomerular filtration rate (eGFR)

    1 year

Other Outcomes (1)

  • graft loss

    1 year

Study Arms (2)

no therapy

NO INTERVENTION

antimicrobial treatment according to in-vitro susceptibility

ACTIVE COMPARATOR
Other: antimicrobial treatment according to in-vitro susceptibility

Interventions

antimicrobial treatment according to in-vitro susceptibilityOTHER
antimicrobial treatment according to in-vitro susceptibility

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Tract InfectionsBacteriuria

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of transplant investigator service

Study Record Dates

First Submitted

March 23, 2014

First Posted

April 15, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2019

Last Updated

April 15, 2014

Record last verified: 2014-04