NCT03399682

Brief Summary

Cystography is a frequent pediatric examination, although indications have been recently restricted . Current indications in our center are:

  • The occurrence of 2 episodes of acute pyelonephritis
  • or 1 episode of pyelonephritis if dilatation of the pelvic ureter\> 5 mm for male children Urinary tract infections that occurred in the month following this test are considered secondary to cystography. However, no recent study has investigated the prevalence of urinary tract infections post cystography. There is no recent epidemiological data on this risk of infection, especially since the management of infections has changed and aseptic precautions during retrograde cystography have evolved with most of the time coverage. antibiotic. The main objective of this multi-center epidemiological prospective study is to perform a recent analysis of the retrograde post-cystographic urinary tract infection rate. Material and methods: Epidemiological, observational, multicenter, prospective study over a period from January 2018 to January 2019. No therapeutic modification will be undertaken at the end of the study. Parents will be called one months after the exam to check if their child had a urinary infection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2018

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

1 month

First QC Date

January 8, 2018

Last Update Submit

January 15, 2018

Conditions

Keywords

cystographypediatryurinary infection

Outcome Measures

Primary Outcomes (1)

  • recent analysis of urinary post cystography infection rate in the pediatric population

    fievre, urine test strip, CBEU

    1 month

Secondary Outcomes (1)

  • infection rate epidemiology

    1 month

Study Arms (1)

Incidence of Post Cystography Urinary Tract Infections

all children less than 16 years having cystography

Diagnostic Test: cystography

Interventions

cystographyDIAGNOSTIC_TEST

observationnal study

Incidence of Post Cystography Urinary Tract Infections

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

all patients under the age of 16 who have had retrograde cystograph

You may qualify if:

  • age: less than 16 years
  • had a retrograd cystography

You may not qualify if:

  • older than 16 years
  • urinary infection in progress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Cystography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

UrographyRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Urological

Study Officials

  • Kassel christophe

    CHU CAEN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

BLOUET marie, MD

CONTACT

ROD Julien, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 16, 2018

Study Start

January 3, 2018

Primary Completion

February 3, 2018

Study Completion

January 31, 2019

Last Updated

January 17, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations