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

Completed

• Conditions: Urinary Tract Infection Bacterial
• Interventions: Other: Any intervention

• Registration Number: NCT04671290
• Lead Sponsor: Centre Hospitalier Annecy Genevois

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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Status Verified: 2020-12
• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-11
• Last Update Submitted: 2020-12-11
• Study First Posted: 2020-12-17
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Any intervention	Carbapenem (imipenem, or meropenem, or ertapenem) as first-line therapy or after receiving up to 72 hours of other antibiotics (including aminoglycosides).
Cases	Any intervention	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Kinetic of fever defervescence	Baseline (day 0), day 3, day 7, day 14	Median fever calculation
Length of hospital stay	3 months after UTI diagnosis	Mean duration of hospital stay
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
Inflammatory biomarkers	Baseline (day 0), day 3, day 7, day 14	CRP level (mg/l)
Relapse of UTI	3 months after antibiotic therapy initiation	Number of patient with a new UTI diagnosis after the end of antibiotic treatment