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Completed

NCT Number: NCT04671290

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

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

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Key information

Conditions

Urinary Tract Infection Bacterial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Any intervention

Other

No intervention

Primary outcomes

  1. Rate of clinical cure

    Time frame: 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 outcomes

  1. Kinetic of fever defervescence

    Time frame: Baseline (day 0), day 3, day 7, day 14

    Median fever calculation

  2. Inflammatory biomarkers

    Time frame: Baseline (day 0), day 3, day 7, day 14

    White blood cells (WBC) count (/mm3)

  3. Inflammatory biomarkers

    Time frame: Baseline (day 0), day 3, day 7, day 14

    CRP level (mg/l)

  4. Length of hospital stay

    Time frame: 3 months after UTI diagnosis

    Mean duration of hospital stay

  5. Relapse of UTI

    Time frame: 3 months after antibiotic therapy initiation

    Number of patient with a new UTI diagnosis after the end of antibiotic treatment

  6. Loss to follow-up, re-hospitalization, and mortality (safety endpoints)

    Time frame: 3 months after antibiotic therapy initiation

    Number of loss to follow-up, re-hospitalization, and mortality

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Annecy Genevois

Other

Collaborators

  • APHP
  • CH Annecy Genevois
  • Hopital Foch
  • Hopitaux Civils de Colmar
  • Sorbonne University

Registry information

Official study title

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

Acronym: TEMO-BLSE

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 17, 2020
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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