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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04671290

Acronym

TEMO-BLSE

Enrollment

144

Registered

2020-12-17

Start date

2015-01-01

Completion date

2019-10-31

Last updated

2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infection Bacterial

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.

Interventions

OTHERAny intervention

No intervention

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Rate of clinical cure	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.

Secondary

Measure	Time frame	Description
Kinetic of fever defervescence	Baseline (day 0), day 3, day 7, day 14	Median fever calculation
Inflammatory biomarkers	Baseline (day 0), day 3, day 7, day 14	White blood cells (WBC) count (/mm3)
Length of hospital stay	3 months after UTI diagnosis	Mean duration of hospital stay
Relapse of UTI	3 months after antibiotic therapy initiation	Number of patient with a new UTI diagnosis after the end of antibiotic treatment
Loss to follow-up, re-hospitalization, and mortality (safety endpoints)	3 months after antibiotic therapy initiation	Number of loss to follow-up, re-hospitalization, and mortality

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026