Temocillin Versus Carbapenems for Urinary Tract Infection Due to ESBL-producing Enterobacteriaceae

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Temocillin Versus Carbapenems for Urinary Tract Infection Due to ESBL-producing Enterobacteriaceae: a Multicenter Case-control Study.

Conditions
-----------------
Urinary Tract Infection Bacterial

Intervention / Treatment
-----------------
* Other: Any intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Multibacterial infection Opposition to data collection according to GDPR

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Carbapenem (imipenem, or meropenem, or ertapenem) as first-line therapy or after receiving up to 72 hours of other antibiotics (including aminoglycosides). | Other: Any intervention<br>* No intervention<br>|
| Cases<br>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). | Other: Any intervention<br>* No intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 14 (End of antibiotic treatment according to national recommendations) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinetic of fever defervescence | Median fever calculation | Baseline (day 0), day 3, day 7, day 14 | 
| Inflammatory biomarkers | White blood cells (WBC) count (/mm3) | Baseline (day 0), day 3, day 7, day 14 | 
| Inflammatory biomarkers | CRP level (mg/l) | Baseline (day 0), day 3, day 7, day 14 | 
| Length of hospital stay | Mean duration of hospital stay | 3 months after UTI diagnosis | 
| Relapse of UTI | Number of patient with a new UTI diagnosis after the end of antibiotic treatment | 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 | 3 months after antibiotic therapy initiation |