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

NCT ID: NCT04671290

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

144 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2019-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Urinary Tract Infection Bacterial

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Control

Carbapenem (imipenem, or meropenem, or ertapenem) as first-line therapy or after receiving up to 72 hours of other antibiotics (including aminoglycosides).

Any intervention

Intervention Type OTHER

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).

Any intervention

Intervention Type OTHER

No intervention

Interventions

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Any intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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APHP

OTHER

Sponsor Role collaborator

Sorbonne University

OTHER

Sponsor Role collaborator

Hopitaux Civils de Colmar

OTHER

Sponsor Role collaborator

Hopital Foch

OTHER

Sponsor Role collaborator

CH Annecy Genevois

OTHER

Sponsor Role collaborator

Centre Hospitalier Annecy Genevois

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mathieu LAFAURIE, M.D

Role: PRINCIPAL_INVESTIGATOR

APHP, St Louis Hospital

Other Identifiers

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19-10

Identifier Type: -

Identifier Source: org_study_id