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Incidence of Post Cystography Urinary Tract Infections in the Pediatric Population (IUCPED)

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ClinicalTrials.gov Identifier: NCT03399682
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : January 17, 2018
Sponsor:
Collaborators:
CH Lisieux
CH Avranches
Information provided by (Responsible Party):
University Hospital, Caen

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.


Condition or disease Intervention/treatment
Urinary Infection Diagnostic Test: cystography

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Incidence of Post Cystography Urinary Tract Infections in the Pediatric Population
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : February 3, 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Incidence of Post Cystography Urinary Tract Infections
all children less than 16 years having cystography
Diagnostic Test: cystography
observationnal study




Primary Outcome Measures :
  1. recent analysis of urinary post cystography infection rate in the pediatric population [ Time Frame: 1 month ]
    fievre, urine test strip, CBEU


Secondary Outcome Measures :
  1. infection rate epidemiology [ Time Frame: 1 month ]
    age, sexe; indication of the test



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients under the age of 16 who have had retrograde cystograph
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • older than 16 years
  • urinary infection in progress

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399682


Contacts
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Contact: BLOUET marie, MD +33231272458 blouet-m@chu-caen.fr
Contact: ROD Julien, MD +33231273120 rod-j@chu-caen.fr

Locations
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France
Caen University Hospital Recruiting
Caen, France, 14000
Contact: Blouet marie, md    +332272458    blouet-m@chu-caen.fr   
Contact: begaud laurie, resident       begaudlaurie@yahoo.fr   
Sub-Investigator: ROD julien, MD         
Sponsors and Collaborators
University Hospital, Caen
CH Lisieux
CH Avranches
Investigators
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Principal Investigator: Kassel christophe CHU Caen

Additional Information:

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03399682     History of Changes
Other Study ID Numbers: 2017-A02445-48
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Caen:
cystography
pediatry
urinary infection

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases