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Status unknownNCT03399682IUCPEDUpdated Jan 17, 2018

Incidence of Post Cystography Urinary Tract Infections in the Pediatric Population

An observational study in Urinary Infection, sponsored by University Hospital, Caen. Status unknown at 1 site in France. Open to participants aged Up to 16 Years. Per ClinicalTrials.gov, last updated 2018-01-17.

Sponsored by University Hospital, Caen · Observational

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
Up to 16 Years
Sex
All
01

Study 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.

Read the detailed description

Cystography is a frequent examination, performed in the context of acute pyelonephritis.

However, its realization has decreased significantly, in particular because of the invasive aspect and urinary infections identified retrospectively. (1) (2) (3) (4)

The only indications to the University Hospital of Caen are:

  • 2 acute pyelonephritis
  • or 1 acute pyelonephritis if the pelvic ureter> 5 mm in boys

There are 2 techniques for performing cystography:

  • The first is retrograde cystography which is performed most often in our center, and whose disadvantages are the traumatic effect and the increased risk of urinary tract infection. (5)
  • The 2nd technique is cystography by the pubic route for which the bladder must be full, which is difficult in newborns not clean The advantages, however, are the ability to take urine directly into the bladder for bacteriological and cytological analysis, to be less traumatic and totally sterile. (5) (6)

Urinary tract infections during the month following cystography are considered secondary to cystography. (7) They are estimated at 6% in old studies (7) However, there is no recent study on the prevalence of urinary tract infections after cystography (article (7): 6%: Complications of voiding cystourethrography in the evaluation of infants with prenatally detected hydronephrosis, The Journal of Urology, 162, 1221-1223, september 1999)

The main objective of our study is therefore to have recent data on the rate of retrograde post cystographic urinary tract infections in the month following the examination.

The secondary objectives are to analyze the rate of urinary tract infections according to age, sex, indications, and circumstances.

Material and method:

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.

Included patients are all children under 16 years of age with retrograde cystography and excluded patients are children over 16 years old and those with ongoing infection.

During the realization of the cystography the information required for the study will be noted, namely:

  • name
  • age
  • sex
  • indication of cystography / ultrasound data
  • antibiotic preventive or not
  • results of cystography
  • antibiotic post cystography or not
  • parental consent and parents' contact information

Clear, fair, and appropriate information about the study is then given to the parents.

They are informed, that with their authorization, they will receive a call to a month of the cystography to know if their child presented a urinary infection (fever, BU and ECBU positive) after the gestexamure.

Their written consent is collected. The data collected after the telephone passages are listed in a table and will be analyzed at the end of the study.

02

Conditions studied

  • Urinary Infection

Keywords

  • cystography
  • pediatry
  • urinary infection
03

Who can participate

Ages eligible
Up to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • older than 16 years
  • urinary infection in progress
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • Incidence of Post Cystography Urinary Tract Infections

    all children less than 16 years having cystography

    Diagnostic Test: cystography

Interventions

  • Diagnostic testcystography

    observationnal study

05

What researchers measure

Primary outcomes

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

    fievre, urine test strip, CBEU

    Time frame: 1 month

Secondary outcomes

  1. infection rate epidemiology

    age, sexe; indication of the test

    Time frame: 1 month

06

Study locations

1 of 1 sites recruiting
  • Caen University Hospital
    Caen, 14000, France
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03399682
Lead sponsor
University Hospital, Caen
Collaborators
CH Lisieux, CH Avranches
Responsible party
Sponsor
First posted
Jan 16, 2018
Start date
Jan 3, 2018
Primary completion
Feb 3, 2018 (estimated)
Completion
Jan 31, 2019 (estimated)
Last update
Jan 17, 2018

Study contacts

BLOUET marie, MD
Contact
blouet-m@chu-caen.fr
+33231272458
ROD Julien, MD
Contact
rod-j@chu-caen.fr
+33231273120
Kassel christophe
principal investigator · CHU Caen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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