Temocillin in ESBL-Enterobacteriaceae Infections

NCT05413772 | Completed

• 1 other identifier: APHP210920
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

Because of the increasing incidence of infections with multi-drug resistant enterobacteriaceae, we need alternative treatments to spare carbapenems. Temocillin could be an interesting option but its position is only defined for the curative treatment of urinary tract infections. We would like to explore others indications comparing two groups : one using temocillin empirically for treatment or prophylaxis and the second using it in second line whatever the indication is.

Conditions

Infectious Disease

Keywords

extended-spectrum-β-lactamase-producing Enterobacteriaceae; carbapenem-sparing agent; urinary tract infection; bacteraemia; temocillin

Outcome Measures

Primary Outcomes (1)

• Number of patients with failure or success

  Definition of failure: persistence of clinical symptoms 72h after starting the antibiotic and/or clinical worsening (ie : fever, cough, sputum, urinary symptoms, diarrhea...) leading to a switch to broad-spectrum antibiotic and/or recurrence of initial symptoms and/or identification of the same bacterial species, retrieved in collection samples, with the same susceptibility pattern as initially observed (same or new location)

  10 days

Secondary Outcomes (1)

• Number of patients with treatment related adverse events as assessed by CTCAE v6.0

  28 days

Study Arms (2)

Temocillin received empirically

Temocillin received in probabilistic , in curative context or in preventive use (prophylaxis)

Other: Temocillin

Temocillin received on second line of treatment

Temocillin received second-line therapy in curative context or in preventive use (prophylaxis)

Other: Temocillin

Interventions

Temocillin OTHER

To evaluate the clinical course of patients who received temocillin. To evaluate the efficacy and safety of temocillin in different situations Enterobacteriaceae ESBL infections

Temocillin received empirically; Temocillin received on second line of treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient over 18, hospitalized in any department from 01/01/16 to 12/15/16 at CHU Pitié-Salpêtrière or CHU Tenon, having received at least 24 hours of temocillin for an ESBL enterobacteria infection / colonization whatever or the indication.

You may qualify if:

• Age ≥ 18 years
• All patients who received at least 24 hours of temocillin for the treatment of ESBL enterobacteriaceae infection / colonization from January to December 2016 in the university hospitals of Tenon and Pitié Salpêtrière. All indications, including excluding recommendations.
• Informed and not opposed to the use of their data

You may not qualify if:

• Patient \< 18 years
• Pregnancy
• Refusal to participate
• Multi-resistant bacterial infection not treated with temocillin
• Temocillin resistant bacteria

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Pitié-Salpêtrière University Hospital

Paris, 75013, France

Location

Tenon University Hospital

Paris, 75020, France

Location

MeSH Terms

Conditions

Communicable Diseases; Urinary Tract Infections; Toxemia

Interventions

temocillin

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Isabelle Bonnet, MD

  Pitie-Salpetriere University Hospital

  PRINCIPAL INVESTIGATOR

• Sophie Vimont, MD

  Tenon Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: June 10, 2022
• Study Start: October 20, 2022
• Primary Completion: November 24, 2022
• Study Completion: November 24, 2022
• Last Updated: February 6, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)