Temocillin Versus Carbapenems for Urinary Tract Infection Due to ESBL-producing Enterobacteriaceae (TEMO-BLSE)

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infection Bacterial
• Intervention / Treatment: Other: Any intervention

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 Type: Observational
• Enrollment (Actual): 144

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; 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; No 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).	Other: Any intervention; No intervention

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Annecy Genevois
• Collaborators: Hopital Foch; APHP; Sorbonne University; Hopitaux Civils de Colmar; CH Annecy Genevois
• Investigators: Principal Investigator: Mathieu LAFAURIE, M.D, APHP, St Louis Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): October 31, 2019
• Study Completion (ACTUAL): October 31, 2019

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (ACTUAL): December 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Urinary Tract Infections; Bacterial Infections
• Other Study ID Numbers: 19-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No