Urinary Tract Infection BacterialTEMO-BLSENCT04671290
Temocillin Versus Carbapenems for Urinary Tract Infection Due to ESBL-producing Enterobacteriaceae
An observational study of Urinary Tract Infection Bacterial, run by Centre Hospitalier Annecy Genevois.
Trial summary
To assess the efficacy of temocillin compared to carbapenems for the management of ESBL-E UTI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection Bacterial
- What is being tested?
- Any intervention
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Oct 2019
- 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: Consecutive adults hospitalized in participating sites for a definite diagnosis of UTI due to an ESBL-producing enterobacteriaceae (ESBL-E) susceptible to carbapenems, were eligible for the study if they provided a non-opposition form for retrospective data collection.
Who may be able to join
- Adults
- Diagnosis of UTI defined by at least two of the following symptoms :chills,temperature >38°C (fever), flank or pelvic pain, nausea or vomiting, dysuria, urinary frequency, or urinary urgency, costovertebral angle tenderness on physical examination
- Positive urine culture with ≥ 103 CFU/mL of a single strain of ESBL-E
- Confirmed ESBL-producing enterobacteriaceae (ESBL-E) susceptible to carbapenems
Who cannot join
- Multibacterial infection
- Opposition to data collection according to GDPR
About this study
Official title: Temocillin Versus Carbapenems for Urinary Tract Infection Due to ESBL-producing Enterobacteriaceae: a Multicenter Case-control Study.
To assess the efficacy of temocillin compared to carbapenems for the management of ESBL-E UTI.
Read the detailed description
Adults with a definite diagnosis of ESBL-E UTI between January-2015 and October-2019 were enrolled in a multicenter retrospective case-control study. Cases were treated with temocillin ≥50% of the effective antibiotic therapy duration. Control exclusively received carbapenem over the effective antibiotic therapy duration.
- Conditions
- Urinary Tract Infection Bacterial
- Being tested
- Any intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Any interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Control | Carbapenem (imipenem, or meropenem, or ertapenem) as first-line therapy or after receiving up to 72 hours of other antibiotics (including aminoglycosides). Receives: Other: Any intervention | |
| Cases | Temocillin above 50% of the time of effective antibiotic therapy duration. Temocillin had to be given as first-line therapy or after receiving a maximum of 5 days of other antibiotics (including carbapenems and aminoglycosides). Receives: Other: Any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical cure
Number of patient in clinical cure is defined as the resolution of fever and symptoms of UTI present at antibiotic initiation (and no new symptoms) and the absence of clinical or microbiological failure.
Measured: Day 14 (End of antibiotic treatment according to national recommendations)
Secondary outcomes (6)
Kinetic of fever defervescence
Median fever calculation
Measured: Baseline (day 0), day 3, day 7, day 14
Inflammatory biomarkers
White blood cells (WBC) count (/mm3)
Measured: Baseline (day 0), day 3, day 7, day 14
Inflammatory biomarkers
CRP level (mg/l)
Measured: Baseline (day 0), day 3, day 7, day 14
Length of hospital stay
Mean duration of hospital stay
Measured: 3 months after UTI diagnosis
Relapse of UTI
Number of patient with a new UTI diagnosis after the end of antibiotic treatment
Measured: 3 months after antibiotic therapy initiation
Loss to follow-up, re-hospitalization, and mortality (safety endpoints)
Number of loss to follow-up, re-hospitalization, and mortality
Measured: 3 months after antibiotic therapy initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jan 2015
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infection BacterialStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Collaborators
- APHP, Sorbonne University, Hopitaux Civils de Colmar, Hopital Foch, CH Annecy Genevois
- Responsible party
- Sponsor
- Investigators
- Mathieu LAFAURIE, M.D, Principal investigator, APHP, St Louis Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671290
- Sponsor's protocol ID
- 19-10
- Acronym
- TEMO-BLSE
- Status last verified
- Dec 2020
- First submitted
- 1 Dec 2020
- Last updated
- 17 Dec 2020
- 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 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temocillin Versus Carbapenems for Urinary Tract Infection Due to ESBL-producing Enterobacteriaceae: a Multicenter Case-control Study.
- ClinicalTrials.gov ID
- NCT04671290
- Acronym / sponsor ID
- TEMO-BLSE / 19-10
- Conditions
- Urinary Tract Infection Bacterial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Collaborators
- APHP, Sorbonne University, Hopitaux Civils de Colmar, Hopital Foch, CH Annecy Genevois
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 17 Dec 2020 (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.
To assess the efficacy of temocillin compared to carbapenems for the management of ESBL-E UTI.
Detailed description
Adults with a definite diagnosis of ESBL-E UTI between January-2015 and October-2019 were enrolled in a multicenter retrospective case-control study. Cases were treated with temocillin ≥50% of the effective antibiotic therapy duration. Control exclusively received carbapenem over the effective antibiotic therapy duration.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Any interventionCarbapenem (imipenem, or meropenem, or ertapenem) as first-line therapy or after receiving up to 72 hours of other antibiotics (including aminoglycosides). |
| Cases | – | Other: Any interventionTemocillin above 50% of the time of effective antibiotic therapy duration. Temocillin had to be given as first-line therapy or after receiving a maximum of 5 days of other antibiotics (including carbapenems and aminoglycosides). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adults hospitalized in participating sites for a definite diagnosis of UTI due to an ESBL-producing enterobacteriaceae (ESBL-E) susceptible to carbapenems, were eligible for the study if they provided a non-opposition form for retrospective data collection.
Key inclusion criteria (4 listed)
- Adults
- Diagnosis of UTI defined by at least two of the following symptoms :chills,temperature >38°C (fever), flank or pelvic pain, nausea or vomiting, dysuria, urinary frequency, or urinary urgency, costovertebral angle tenderness on physical examination
- Positive urine culture with ≥ 103 CFU/mL of a single strain of ESBL-E
- Confirmed ESBL-producing enterobacteriaceae (ESBL-E) susceptible to carbapenems
Key exclusion criteria (2 listed)
- Multibacterial infection
- Opposition to data collection according to GDPR
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 |
|---|---|---|
| Any interventionNo intervention | Other | Cases, Control |
Primary outcome
Rate of clinical cure
Time frame: Day 14 (End of antibiotic treatment according to national recommendations)
Number of patient in clinical cure is defined as the resolution of fever and symptoms of UTI present at antibiotic initiation (and no new symptoms) and the absence of clinical or microbiological failure.
6 secondary outcomes
Kinetic of fever defervescence
Time frame: Baseline (day 0), day 3, day 7, day 14
Inflammatory biomarkers
Time frame: Baseline (day 0), day 3, day 7, day 14
Inflammatory biomarkers
Time frame: Baseline (day 0), day 3, day 7, day 14
Length of hospital stay
Time frame: 3 months after UTI diagnosis
Relapse of UTI
Time frame: 3 months after antibiotic therapy initiation
Loss to follow-up, re-hospitalization, and mortality (safety endpoints)
Time frame: 3 months after antibiotic therapy initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- 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.
Mathieu LAFAURIE, M.D principal investigator
APHP, St Louis Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infection Bacterial, run by Centre Hospitalier Annecy Genevois.
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 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: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clinical cure (time frame: Day 14 (End of antibiotic treatment according to national recommendations)). 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 Dec 2020.