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

NCT04671290 | Completed

• 1 other identifier: 19-10
• Study Type: observational
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Urinary Tract Infection Bacterial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Kinetic of fever defervescence

  Baseline (day 0), day 3, day 7, day 14

• Inflammatory biomarkers

  Baseline (day 0), day 3, day 7, day 14

• Inflammatory biomarkers

  Baseline (day 0), day 3, day 7, day 14

• Length of hospital stay

  3 months after UTI diagnosis

• Relapse of UTI

  3 months after antibiotic therapy initiation

Study Arms (2)

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

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

Interventions

Any intervention OTHER

No intervention

Cases; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Multibacterial infection
• Opposition to data collection according to GDPR

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead
• APHP: collaborator
• Sorbonne University: collaborator
• Hopitaux Civils de Colmar: collaborator
• Hopital Foch: collaborator
• CH Annecy Genevois: collaborator

Study Officials

• Mathieu LAFAURIE, M.D

  APHP, St Louis Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 17, 2020
• Study Start: January 1, 2015
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share