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

Urinary Tract Infection Bacterial Clinical Trial

— TEMO-BLSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04671290
• Other study ID #: 19-10
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: October 31, 2019

Study information

• Verified date: December 2020
• Source: Centre Hospitalier Annecy Genevois
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess the efficacy of temocillin compared to carbapenems for the management of ESBL-E UTI.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection
• Urinary Tract Infection Bacterial
• Urinary Tract Infections

Intervention

Other:
• Any intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Centre Hospitalier Annecy Genevois	APHP, CH Annecy Genevois, Hopital Foch, Hopitaux Civils de Colmar, Sorbonne University

Outcome

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