Kidney TransplantationURIKITNCT03211026
Urinary Tract Infections in Kidney Transplant Recipients
An observational study of Kidney Transplantation, run by Poitiers University Hospital at 1 site in France.
Trial summary
The purpose of this study is to better estimate the prevalence of urinary tract infections (UTI) in kidney transplant (KIT) recipients, and especially multidrug resistant (MDR) bacteria. KIT recipients have a higher risk of UTI over the 6 first months following the transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2017to 4 May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female
Who may be able to join
- Age ≥ 18 year-old
- Kidney transplanted for less than 5 years
- First symptomatic episode of UTI with bacteria or yeast
- To have a health insurance
Who cannot join
- Asymptomatic bacteriuria or candiduria
- Protected people
- Pregnant women -> 2 bacteria in the urinalysis without external or internal urinary catheter
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Poitiers
Poitiers, 86000
Blandine RAMMAERT, PhD, 0549444422, blandine.rammaert.paltrie@univ-poitiers.fr
Antoine THIERRY, PhD
About this study
Official title: Urinary Tract Infections in Kidney Transplant Recipients : an Observational Cohort
The purpose of this study is to better estimate the prevalence of urinary tract infections (UTI) in kidney transplant (KIT) recipients, and especially multidrug resistant (MDR) bacteria. KIT recipients have a higher risk of UTI over the 6 first months following the transplantation. Urine culture was done in a city lab or at hospital. Current data on bacteriuria and candiduria lead mostly to hospital data that are incomplete..
Read the detailed description
The risk of UTI after a kidney transplantation is higher than in the general population. MDR bacteria, such as extended spectrum betalactamase (ESBL)-producing enterobacteriaceae or MDR Pseumomoas aeruginosa are emerging threats due to antibiotic selective pressure. Epidemiological data are mostly data from hospital laboratories that do not show a complete overview of the current situation. In addition, the different centers which participated to this study received before the beginning of the study a protocol to avoid carbapenem use. The main objective of this study is to assess the prevalence of MDR bacteria in an adult population of KIT recipients. Through this study, the management of UTI in KIT recipients will be improved. Data on bacteria or yeasts responsible for UTI (identification, resistance profile), antibiotic use, patients' outcome, and graft outcome will be collected.
- Conditions
- Kidney Transplantation
- Being tested
- No intervention
- Keywords
- Urinary tract infection, Multidrug resistant bacteria, Candiduria, Epidemiology, Graft rejection, Solid organ transplantation
- 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.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of UTI due to MDR bacteria
Proportion of MDR bacteria compared to other bacteria found in urinalysis of symptomatic KIT patients
Measured: Day 0 to 2 years
Secondary outcomes (9)
Epidemiology of UTI in KIT recipients
Frequency of each bacteria or yeasts responsible for UTI
Measured: Day 0 to 2 years
Risk factors for MDR UTI
Comparison of demographic and clinical characteristic of patients who develop an MDR versus a non-MDR UTI
Measured: Day 0 to 2 years
Carbapenem use to treat UTI
Proportion of patients who received carbapenem for UTI treatment
Measured: Day 0 to 2 years
Coherence between antibiotic protocol and treatment received to treat UTI
Proportion of patients who received carbapenem while responsible bacteria was susceptible to other antibiotics
Measured: Day 0 to 2 years
UTI relapse frequency
Proportion of patients with at least one relaspe of UTI with the same bacteria
Measured: Day 0 to 2 years
UTI recurrence frequency with a different micororganism
Proportion of patients with more than one UTI during the study period
Measured: Day 0 to 2 years
Assessment of kidney function during the observation period
Difference between the initial kidney function (MDRD) and the final kidney function at the end of the observation period
Measured: Day 0 to 2 years
Graft outcome
Number of patients needed a dialysis
Measured: Day 0 to 2 years
Patients outcome
Number of deaths
Measured: Day 0 to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start4 May 2017
- Primary completion4 May 2022 (estimated)
- Study completion4 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Antoine THIERRY, PHD, Principal investigator, Poitiers University HospitalBlandine RAMMAERT, Study director, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211026
- Sponsor's protocol ID
- 2016-A02081-50
- Acronym
- URIKIT
- Status last verified
- Apr 2021
- First submitted
- 23 Jun 2017
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan will be sharing with others researchers
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Tract Infections in Kidney Transplant Recipients : an Observational Cohort
- ClinicalTrials.gov ID
- NCT03211026
- Acronym / sponsor ID
- URIKIT / 2016-A02081-50
- Conditions
- Kidney Transplantation
- Keywords
- Urinary tract infection, Multidrug resistant bacteria, Candiduria, Epidemiology, Graft rejection, Solid organ transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 4 May 2017 (actual)
- Primary completion
- 4 May 2022 (estimated)
- Study completion
- 4 May 2024 (estimated)
- First posted
- 7 Jul 2017 (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.
The purpose of this study is to better estimate the prevalence of urinary tract infections (UTI) in kidney transplant (KIT) recipients, and especially multidrug resistant (MDR) bacteria. KIT recipients have a higher risk of UTI over the 6 first months following the transplantation. Urine culture was done in a city lab or at hospital. Current data on bacteriuria and candiduria lead mostly to hospital data that are incomplete..
Detailed description
The risk of UTI after a kidney transplantation is higher than in the general population. MDR bacteria, such as extended spectrum betalactamase (ESBL)-producing enterobacteriaceae or MDR Pseumomoas aeruginosa are emerging threats due to antibiotic selective pressure. Epidemiological data are mostly data from hospital laboratories that do not show a complete overview of the current situation. In addition, the different centers which participated to this study received before the beginning of the study a protocol to avoid carbapenem use. The main objective of this study is to assess the prevalence of MDR bacteria in an adult population of KIT recipients. Through this study, the management of UTI in KIT recipients will be improved. Data on bacteria or yeasts responsible for UTI (identification, resistance profile), antibiotic use, patients' outcome, and graft outcome will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female
Key inclusion criteria (4 listed)
- Age ≥ 18 year-old
- Kidney transplanted for less than 5 years
- First symptomatic episode of UTI with bacteria or yeast
- To have a health insurance
Key exclusion criteria (3 listed)
- Asymptomatic bacteriuria or candiduria
- Protected people
- Pregnant women -> 2 bacteria in the urinalysis without external or internal urinary catheter
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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Assessment of UTI due to MDR bacteria
Time frame: Day 0 to 2 years
Proportion of MDR bacteria compared to other bacteria found in urinalysis of symptomatic KIT patients
9 secondary outcomes
Epidemiology of UTI in KIT recipients
Time frame: Day 0 to 2 years
Risk factors for MDR UTI
Time frame: Day 0 to 2 years
Carbapenem use to treat UTI
Time frame: Day 0 to 2 years
Coherence between antibiotic protocol and treatment received to treat UTI
Time frame: Day 0 to 2 years
UTI relapse frequency
Time frame: Day 0 to 2 years
UTI recurrence frequency with a different micororganism
Time frame: Day 0 to 2 years
Assessment of kidney function during the observation period
Time frame: Day 0 to 2 years
Graft outcome
Time frame: Day 0 to 2 years
Patients outcome
Time frame: Day 0 to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: No. No plan will be sharing with others researchers
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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.
Antoine THIERRY, PHD principal investigator
Poitiers University Hospital
Blandine RAMMAERT study director
Poitiers University Hospital
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 Kidney Transplantation, run by Poitiers University Hospital 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 4 inclusion and 3 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 14 Apr 2021. 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 Isabelle PIRONNEAU (0549443203, isabelle.pironneau@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of UTI due to MDR bacteria (time frame: Day 0 to 2 years). 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 14 Apr 2021.