Urinary InfectionIUCPEDNCT03399682
Incidence of Post Cystography Urinary Tract Infections in the Pediatric Population
An observational study of Urinary Infection, run by University Hospital, Caen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Urinary Infection
- What is being tested?
- cystography
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2018to 31 Jan 2019
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: all patients under the age of 16 who have had retrograde cystograph
Who may be able to join
- age: less than 16 years
- had a retrograd cystography
Who cannot join
- older than 16 years
- urinary infection in progress
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, 14000
Blouet marie, md, +332272458, blouet-m@chu-caen.fr
begaud laurie, resident, begaudlaurie@yahoo.fr
About this study
Cystography is a frequent pediatric examination, although indications have been recently restricted .
Current indications in our center are:
Read more
- 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.
- Conditions
- Urinary Infection
- Being tested
- cystography
- Keywords
- cystography, pediatry, urinary infection
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cystographyDiagnostic test
observationnal study
| Study group | Role | What they receive |
|---|---|---|
| Incidence of Post Cystography Urinary Tract Infections | all children less than 16 years having cystography Receives: Diagnostic Test: cystography |
What is being measured
The primary outcome is the main question the study is designed to answer.
recent analysis of urinary post cystography infection rate in the pediatric population
fievre, urine test strip, CBEU
Measured: 1 month
Secondary outcomes (1)
infection rate epidemiology
age, sexe; indication of the test
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start3 Jan 2018
- Primary completion3 Feb 2018 (estimated)
- Study completion31 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- CH Lisieux, CH Avranches
- Responsible party
- Sponsor
- Investigators
- Kassel christophe, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399682
- Sponsor's protocol ID
- 2017-A02445-48
- Acronym
- IUCPED
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2018
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Post Cystography Urinary Tract Infections in the Pediatric Population
- ClinicalTrials.gov ID
- NCT03399682
- Acronym / sponsor ID
- IUCPED / 2017-A02445-48
- Conditions
- Urinary Infection
- Keywords
- cystography, pediatry, urinary infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- CH Lisieux, CH Avranches
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 3 Feb 2018 (estimated)
- Study completion
- 31 Jan 2019 (estimated)
- First posted
- 16 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Incidence of Post Cystography Urinary Tract Infections | – | Diagnostic Test: cystographyall children less than 16 years having cystography |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- all patients under the age of 16 who have had retrograde cystograph
Key inclusion criteria (2 listed)
- age: less than 16 years
- had a retrograd cystography
Key exclusion criteria (2 listed)
- older than 16 years
- urinary infection in progress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cystographyobservationnal study | Diagnostic test | Incidence of Post Cystography Urinary Tract Infections |
Primary outcome
recent analysis of urinary post cystography infection rate in the pediatric population
Time frame: 1 month
fievre, urine test strip, CBEU
1 secondary outcome
infection rate epidemiology
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kassel christophe principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Infection, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BLOUET marie, MD (+33231272458, blouet-m@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recent analysis of urinary post cystography infection rate in the pediatric population (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.