NCT01871753

Brief Summary

The purpose of this study is to compare antibiotics versus no-treatment in kidney transplant recipients with asymptomatic bacteriuria.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_4

Geographic Reach
2 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

5.3 years

First QC Date

May 31, 2013

Last Update Submit

July 16, 2019

Conditions

Asymptomatic BacteriuriaBacteriuriaUrinary Tract InfectionsKidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • cumulative incidence of a first episode of symptomatic urinary tract infection

    12 months

Secondary Outcomes (12)

  • incidence of a first episode of pyelonephritis

    12 months

  • clearance of asymptomatic bacteriuria

    12 months

  • occurrence of new episodes of asymptomatic bacteriuria

    12 months

  • graft function/graft survival

    12 months

  • incidence of graft rejection

    12 months

  • +7 more secondary outcomes

Study Arms (2)

Antibiotics

EXPERIMENTAL

10 days of antibiotics, started and selected according to the antibiogram results. In case of reinfection or relapse, re-administration of antimicrobial agents will be performed according to the antibiogram results (for a maximum of 3 cycles of ten days of antibiotics during the 12 months of the follow-up).

Other: Anti-Infective Agents

No treatment

NO INTERVENTION

no antibiotics delivered in case of asymptomatic bacteriuria, independently of the number of asymptomatic episodes.

Interventions

Anti-Infective AgentsOTHER

10 days of antibiotics, started and selected according to the antibiogram results. In case of reinfection or relapse, re-administration of antimicrobial agents will be performed according to the antibiogram results (for a maximum of 3 cycles of ten days of antibiotics during the 12 months of the follow-up)

Also known as: Anti-Infective Agents: not applicable - no specific agent, The choice of antimicrobial agent is at the discretion of the physician, and is based on the antibiogram results
Antibiotics

Eligibility Criteria

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

You may qualify if:

  • Kidney transplant recipient with asymptomatic bacteriuria after the first two months post-transplantation

You may not qualify if:

  • Pregnant women or women who wish to become pregnant during the course of the study
  • Presence of indwelling urinary devices such as urethral catheter, ureteral catheter, nephrostomy and/or suprapubic catheter
  • Combined transplantation (liver-kidney, lung-kidney, heart-kidney)
  • Urinary tract surgery during the last two months
  • Surgical urological procedure planned in the next 2 weeks
  • Neutropenia (≤ 500 neutrophils/mm3)
  • Important intensification of immunosuppression (Solumedrol bolus and/or use of thymoglobulin) or any other treatment of an acute graft rejection in the last two months
  • Use of antibiotics at the time of the asymptomatic bacteriuria (except for prevention of Pneumocystis jirovecii)
  • End-Stage Renal Disease (ESRD) requiring dialysis
  • Non-functioning native bladder (e.g. bladder dysfunction requiring intermittent self-catheterization, orthotopic ileal neobladder)
  • Recurrent acute graft pyelonephritis (≥ 2 episodes in the last year)
  • Kidney transplant recipients who could not return for regular follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Universitair Ziekenhuis Antwerpen

Antwerp, 2650, Belgium

Location

Centre Hospitalier Epicura

Baudour, 7331, Belgium

Location

Centre Hospitalier Universitaire Brugmann

Brussels, 1020, Belgium

Location

Hôpital Universitaire Erasme

Brussels, 1070, Belgium

Location

Universitair Ziekenhuis Brussel - Vrije Universiteit Brussel

Brussels, 1090, Belgium

Location

Centre Hospitalier Universitaire de Charleroi

Charleroi, 6110, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Location

Groupe Henri Mondor-Albert Chenevier, Assistance Publique-Hôpitaux de Paris

Créteil, 94000, France

Location

Centre Hospitalier Régional Universitaire de Lille

Lille, 59037, France

Location

Centre Hospitalier Universitaire de Nantes

Nantes, 44000, France

Location

Department of Kidney Transplantation, Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP

Paris, 75015, France

Location

Hôpital Tenon, Assistance Publique-Hôpitaux de Paris

Paris, 75020, France

Location

Centre Hospitalier Universitaire de Saint-Étienne

Saint-Etienne, 42055, France

Location

Centre Hospitalier Universitaire Rangueil

Toulouse, 31059, France

Location

MeSH Terms

Conditions

BacteriuriaUrinary Tract Infections

Interventions

Anti-Infective Agents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Julien Coussement, MD

    Hôpital Universitaire Erasme, Brussels, Belgium

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Julien Coussement, MD

Study Record Dates

First Submitted

May 31, 2013

First Posted

June 7, 2013

Study Start

April 1, 2014

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 18, 2019

Record last verified: 2019-07

Locations

FR(7)BE(8)