Urinary Tract InfectionsPODIUMNCT05847036
Profiles of Urinary Tract Infections in General Practice
An observational study of Urinary Tract Infections, run by CNGE Conseil at 1 site in France.
Trial summary
Urinary tract infections (UTIs) are one of the most common bacterial infections managed in general practice: they are the 2nd site of community-acquired bacterial infection after respiratory infections (4-6 million consultations per year in France). UTIs represent 15% of total antibiotic prescriptions in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2023to 31 Jan 2025
- 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: Adult patients consulting in general practice for suspected urinary tract infection
Who may be able to join
- Patient ≥18 years old
- Patient presenting one or more of the following clinical signs suggestive of urinary tract infection in general practice consultation:
- fever (temperature > 38°C)
- chills, sweats
- burning urination
- urinary urgency
Show all 31Show fewer
- pollakiuria
- dysuria
- lumbar and/or pelvic pain
- abnormal urine appearance: cloudy, malodorous, macroscopic haematuria
- absence of leucorrhoea
- specifically in people > 70 years old:
- recent onset urinary incontinence
- sudden confusion
- bladder globe
- Positive urine dipstick and/or positive Cytobacteriological Examination of Urine (CBEU)
- Patient affiliated with the French National Health Insurance or beneficiary of such a scheme.
- Patient's oral non-opposition of participation in the study after receiving complete information about the protocol
- Non-inclusion Criteria:
- Patient < 18 years old
- Declared pregnancy
- Patient with indwelling urinary catheter
- Patient with functional or organic abnormality of the urinary tract
- Patient with known severe immunodeficiency (HIV+ with CD4 count < 200/mm3, organ transplant, bone marrow transplant, patient on immunosuppressants, cirrhosis)
- Patient with known severe chronic renal failure (clearance < 30 mL/min)
- Patient previously treated with an antibiotic (for an other reason than a urinary tract infection and/or treatment failure of the urinary tract infection) in the past month before the inclusion consultation
- Patient speaking little or no French
- Patient with severe cognitive impairment
- Patient with life expectancy < 3 months
- Patient under legal protection, inability to give an oral non-opposition
- Patient with severity criteria justifying hospitalization
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Cabinet de groupe
Saint-Maur-des-Fossés, Saint Maur, 94100
Véronique Orcel, Dr, 06.68.53.69.92, veronique.orcel@laposte.net
About this study
Official title: Profiles of Urinary Tract Infections in General Practice : a Prospective Multicentre Cohort Study
Urinary tract infections (UTIs) are one of the most common bacterial infections managed in general practice: they are the 2nd site of community-acquired bacterial infection after respiratory infections (4-6 million consultations per year in France).
UTIs represent 15% of total antibiotic prescriptions in France. Antibiotics recommended for UTIs, except for cystitis, are considered as "critical" (highly generating bacterial resistances). UTIs are a potential source of antibiotic resistance: often inappropriate antibiotic prescriptions, evolution of the resistance profiles of the bacteria involved, emergence of multi-resistant strains.
Read more
The first hypothesis is that there are other profiles of clinical UTI situations in general practice than typical cystitis or pyelonephritis, including intermediate forms.
The second hypothesis is that these intermediate forms of UTI are subject to longer durations of antibiotherapy, and that probable explanatory factors need to be identified.
Read the detailed description
Urinary tract infections (UTIs) are one of the most common bacterial infections managed in general practice: they are the 2nd site of community-acquired bacterial infection after respiratory infections (4-6 million consultations per year in France).
UTIs represent 15% of total antibiotic prescriptions in France. Antibiotics recommended for UTIs, except for cystitis, are considered as "critical" (highly generating bacterial resistances). UTIs are a potential source of antibiotic resistance: often inappropriate antibiotic prescriptions, evolution of the resistance profiles of the bacteria involved, emergence of multi-resistant strains.
Current guidelines classify UTIs as "uncomplicated UTI" (cystitis and pyelonephritis) and "UTI at risk of complication" (cystitis, pyelonephritis and male UTI) [1-2]. However, in primary care, pathologies are diagnosed at an early stage: the clinical signs usually described by scientific societies are not always all found, and the descriptions are not always adapted to the realities encountered in general practice [3-6]. Some clinical situations do not fit into the systematic categories of the guidelines, with "intermediate" forms (such as pain in the lumbar fossae without fever "cysphritis" or other atypical presentations) [3]. The current literature in general practice highlights these issues: the need for prospective cohorts in real-life practice to identify these profiles and develop more appropriate guidelines [3-6]. Treatment for these intermediate forms is not obvious and is often empirical: potentially longer antibiotherapies, with possible worsening of antibiotic resistance [7].
The first hypothesis is that there are other profiles of clinical UTI situations in general practice than typical cystitis or pyelonephritis, including intermediate forms.
The second hypothesis is that these intermediate forms of UTI are subject to longer durations of antibiotherapy, and that probable explanatory factors need to be identified.
- Conditions
- Urinary Tract Infections
- Medical subject headings
- Urinary Tract Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the number of homogeneous profiles of patients with UTI in general practice and their characteristics using clinico-bacteriological indicators.
The primary outcome will be the rate and the clinical-bacteriological characteristics of the identified profiles of patients with UTI in general practice
Measured: At Day 14 after the end of the Antiobiotic treatment
Secondary outcomes (4)
For general practioners' practices:
Percentage of cytobacteriological examination of urine (CBEUs) prescribed
- Number and type of additional examinations prescribed
- Percentage of antibiotics prescribed, therapeutic class chosen, duration (in ordinal categories), posology
Measured: At Day 0, at Day 14 after the end of the treatment and between Day 0 and Day14 after the end of the treatment
For short-term evolutionary trajectories:
Number of consultations (in general practice or other specialty) and reasons
- Number of emergency department visits
- Number of unscheduled hospitalizations related to UTI
Measured: At Day 0, at Day 14 after the end of the treatment and between Day 0 and Day 14 after the end of the treatment
For short-term evolutionary trajectories:
Percentage of patients with worsening, stability or recovery of their symptoms as final condition (based on clinical assessment by GPs during a consultation at day 14)
Measured: At Day 14 after the end of the treatment
For the factors associated with the prescription of antibiotics:
Percentage of antibiotics prescribed, Choice of antibiotic class, whether 'delayed' or immediate, duration, posology
Measured: At Day 14 after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start15 Dec 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CNGE Conseil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique ORCEL, Dr, Principal investigator, Département Universitaire d'Enseignement et de Recherche de Médecine Générale de Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847036
- Sponsor's protocol ID
- CNGE-2021-05
- Acronym
- PODIUM
- Status last verified
- Jul 2024
- First submitted
- 7 Apr 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Caron F, Galperine T, Flateau C, Azria R, Bonacorsi S, Bruyere F, Cariou G, Clouqueur E, Cohen R, Doco-Lecompte T, Elefant E, Faure K, Gauzit R, Gavazzi G, Lemaitre L, Raymond J, Senneville E, Sotto A, Subtil D, Trivalle C, Merens A, Etienne M. Practice guidelines for the management of adult community-acquired urinary tract infections. Med Mal Infect. 2018 Aug;48(5):327-358. doi: 10.1016/j.medmal.2018.03.005. Epub 2018 May 16. No abstract available.
PubMed 29759852Grigoryan L, Trautner BW, Gupta K. Diagnosis and management of urinary tract infections in the outpatient setting: a review. JAMA. 2014 Oct 22-29;312(16):1677-84. doi: 10.1001/jama.2014.12842.
PubMed 25335150Soudais B, Lacroix-Hugues V, Meunier F, Gillibert A, Darmon D, Schuers M. Diagnosis and management of male urinary tract infections: a need for new guidelines. Study from a French general practice electronic database. Fam Pract. 2021 Jul 28;38(4):432-440. doi: 10.1093/fampra/cmaa136.
PubMed 33340317Kinouani S, de Lary de Latour H, Joseph JP, Letrilliart L. Diagnostic strategies for urinary tract infections in French general practice. Med Mal Infect. 2017 Oct;47(6):401-408. doi: 10.1016/j.medmal.2017.05.003. Epub 2017 Jun 9.
PubMed 28606664Vincent YM, Frachon A, Buffeteau C, Conort G. Construction of a patient decision aid for the treatment of uncomplicated urinary tract infection in primary care. BMC Fam Pract. 2021 Jan 26;22(1):26. doi: 10.1186/s12875-021-01374-3.
PubMed 33499824Piraux A, Faure S, Naber KG, Alidjanov JF, Ramond-Roquin A. Changes in the management of urinary tract infections in women: impact of the new recommendations on antibiotic prescribing behavior in France, between 2014 and 2019. BMC Health Serv Res. 2021 Jun 28;21(1):612. doi: 10.1186/s12913-021-06653-4.
PubMed 34182991Lugtenberg M, Burgers JS, Zegers-van Schaick JM, Westert GP. Guidelines on uncomplicated urinary tract infections are difficult to follow: perceived barriers and suggested interventions. BMC Fam Pract. 2010 Jun 28;11:51. doi: 10.1186/1471-2296-11-51.
PubMed 20584276
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiles of Urinary Tract Infections in General Practice : a Prospective Multicentre Cohort Study
- ClinicalTrials.gov ID
- NCT05847036
- Acronym / sponsor ID
- PODIUM / CNGE-2021-05
- Conditions
- Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- CNGE ConseilUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 6 May 2023 (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.
Urinary tract infections (UTIs) are one of the most common bacterial infections managed in general practice: they are the 2nd site of community-acquired bacterial infection after respiratory infections (4-6 million consultations per year in France).
UTIs represent 15% of total antibiotic prescriptions in France. Antibiotics recommended for UTIs, except for cystitis, are considered as "critical" (highly generating bacterial resistances). UTIs are a potential source of antibiotic resistance: often inappropriate antibiotic prescriptions, evolution of the resistance profiles of the bacteria involved, emergence of multi-resistant strains.
The first hypothesis is that there are other profiles of clinical UTI situations in general practice than typical cystitis or pyelonephritis, including intermediate forms.
The second hypothesis is that these intermediate forms of UTI are subject to longer durations of antibiotherapy, and that probable explanatory factors need to be identified.
Detailed description
Urinary tract infections (UTIs) are one of the most common bacterial infections managed in general practice: they are the 2nd site of community-acquired bacterial infection after respiratory infections (4-6 million consultations per year in France).
UTIs represent 15% of total antibiotic prescriptions in France. Antibiotics recommended for UTIs, except for cystitis, are considered as "critical" (highly generating bacterial resistances). UTIs are a potential source of antibiotic resistance: often inappropriate antibiotic prescriptions, evolution of the resistance profiles of the bacteria involved, emergence of multi-resistant strains.
Current guidelines classify UTIs as "uncomplicated UTI" (cystitis and pyelonephritis) and "UTI at risk of complication" (cystitis, pyelonephritis and male UTI) [1-2]. However, in primary care, pathologies are diagnosed at an early stage: the clinical signs usually described by scientific societies are not always all found, and the descriptions are not always adapted to the realities encountered in general practice [3-6]. Some clinical situations do not fit into the systematic categories of the guidelines, with "intermediate" forms (such as pain in the lumbar fossae without fever "cysphritis" or other atypical presentations) [3]. The current literature in general practice highlights these issues: the need for prospective cohorts in real-life practice to identify these profiles and develop more appropriate guidelines [3-6]. Treatment for these intermediate forms is not obvious and is often empirical: potentially longer antibiotherapies, with possible worsening of antibiotic resistance [7].
The first hypothesis is that there are other profiles of clinical UTI situations in general practice than typical cystitis or pyelonephritis, including intermediate forms.
The second hypothesis is that these intermediate forms of UTI are subject to longer durations of antibiotherapy, and that probable explanatory factors need to be identified.
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
- Adult patients consulting in general practice for suspected urinary tract infection
Key inclusion criteria (31 listed)
- Patient ≥18 years old
- Patient presenting one or more of the following clinical signs suggestive of urinary tract infection in general practice consultation:
- Positive urine dipstick and/or positive Cytobacteriological Examination of Urine (CBEU)
- Patient affiliated with the French National Health Insurance or beneficiary of such a scheme.
- Patient's oral non-opposition of participation in the study after receiving complete information about the protocol
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome will be the number of homogeneous profiles of patients with UTI in general practice and their characteristics using clinico-bacteriological indicators.
Time frame: At Day 14 after the end of the Antiobiotic treatment
The primary outcome will be the rate and the clinical-bacteriological characteristics of the identified profiles of patients with UTI in general practice
4 secondary outcomes
For general practioners' practices:
Time frame: At Day 0, at Day 14 after the end of the treatment and between Day 0 and Day14 after the end of the treatment
For short-term evolutionary trajectories:
Time frame: At Day 0, at Day 14 after the end of the treatment and between Day 0 and Day 14 after the end of the treatment
For short-term evolutionary trajectories:
Time frame: At Day 14 after the end of the treatment
For the factors associated with the prescription of antibiotics:
Time frame: At Day 14 after the end of the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 29759852Caron F, Galperine T, Flateau C, Azria R, Bonacorsi S, Bruyere F, Cariou G, Clouqueur E, Cohen R, Doco-Lecompte T, Elefant E, Faure K, Gauzit R, Gavazzi G, Lemaitre L, Raymond J, Senneville E, Sotto A, Subtil D, Trivalle C, Merens A, Etienne M. Practice guidelines for the management of adult community-acquired urinary tract infections. Med Mal Infect. 2018 Aug;48(5):327-358. doi: 10.1016/j.medmal.2018.03.005. Epub 2018 May 16. No abstract available.
- Background: PubMed 25335150Grigoryan L, Trautner BW, Gupta K. Diagnosis and management of urinary tract infections in the outpatient setting: a review. JAMA. 2014 Oct 22-29;312(16):1677-84. doi: 10.1001/jama.2014.12842.
- Background: PubMed 33340317Soudais B, Lacroix-Hugues V, Meunier F, Gillibert A, Darmon D, Schuers M. Diagnosis and management of male urinary tract infections: a need for new guidelines. Study from a French general practice electronic database. Fam Pract. 2021 Jul 28;38(4):432-440. doi: 10.1093/fampra/cmaa136.
- Background: PubMed 28606664Kinouani S, de Lary de Latour H, Joseph JP, Letrilliart L. Diagnostic strategies for urinary tract infections in French general practice. Med Mal Infect. 2017 Oct;47(6):401-408. doi: 10.1016/j.medmal.2017.05.003. Epub 2017 Jun 9.
- Background: PubMed 33499824Vincent YM, Frachon A, Buffeteau C, Conort G. Construction of a patient decision aid for the treatment of uncomplicated urinary tract infection in primary care. BMC Fam Pract. 2021 Jan 26;22(1):26. doi: 10.1186/s12875-021-01374-3.
- Background: PubMed 34182991Piraux A, Faure S, Naber KG, Alidjanov JF, Ramond-Roquin A. Changes in the management of urinary tract infections in women: impact of the new recommendations on antibiotic prescribing behavior in France, between 2014 and 2019. BMC Health Serv Res. 2021 Jun 28;21(1):612. doi: 10.1186/s12913-021-06653-4.
- Background: PubMed 20584276Lugtenberg M, Burgers JS, Zegers-van Schaick JM, Westert GP. Guidelines on uncomplicated urinary tract infections are difficult to follow: perceived barriers and suggested interventions. BMC Fam Pract. 2010 Jun 28;11:51. doi: 10.1186/1471-2296-11-51.
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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.
Véronique ORCEL, Dr principal investigator
Département Universitaire d'Enseignement et de Recherche de Médecine Générale de Créteil
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 Tract Infections, run by CNGE Conseil 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 31 inclusion and 0 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 3 Jul 2024. 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 Véronique ORCEL, Dr (01 42 83 59 68, veronique.orcel@laposte.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be the number of homogeneous profiles of patients with UTI in general practice and their characteristics using clinico-bacteriological indicators. (time frame: At Day 14 after the end of the Antiobiotic treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05847036, which also lists 7 linked publications.
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 3 Jul 2024.